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U.S. Environmental Protection Agency
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National Center for Environmental Research
Science to Achieve Results (STAR) Program

CLOSED - FOR REFERENCES PURPOSES ONLY

Centers for Children's Environmental Health and Disease Prevention Research

Opening Date: January 27, 2003
Closing Date: May 16, 2003

RFA: ES-03-004

National Institute of Environmental Health Sciences
http://www.niehs.nih.gov
National Center for Environmental Research, U.S. Environmental Protection Agency
http://www.epa.gov/ncer/

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
66.500, 93.113, 93.114, 93.115

Letter of Intent Receipt Date: April 16, 2003
Application Receipt Date: May 16, 2003

Summary of Program Requirements
Purpose of this RFA
Research Objectives
Mechanism(s) of Support
Funds Available
Eligible Institutions
Individuals Eligible to Become Principal Investigators
Special Requirements
Where to Send Inquiries
Letter of Intent
Submitting an Application
Peer Review Process
Review Criteria
Receipt and Review Schedule
Award Criteria
Required Federal Citations


SUMMARY OF PROGRAM REQUIREMENTS
General Information

Program Title:

Centers for Children's Environmental Health and Disease Prevention Research

Synopsis of Program:

The National Institute of Environmental Health Sciences (NIEHS) and the US Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, are seeking applications for Centers that will conduct multidisciplinary basic and applied research in combination with community-based research projects on environmental threats to children's health and translate those research findings to public policy, community needs, and information for the health care community and for the general public. This Center program emphasizes integration of laboratory and population science while applying community-based participatory research (CBPR) strategies. 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. This program focuses on the impact of environmental exposures on the etiology and prevention of a variety of health concerns in young 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 it relates to brain and other organ systems growth and development through young adulthood. Specifically, disease areas such as respiratory diseases, neurodevelopment and neurobehavior, childhood cancers, birth defects, and other conditions can be included for study. The spectrum of scientific approaches would include the following disciplines: mechanistic research including pathophysiology of target-organ system; toxicological research; molecular and cellular sciences; clinical research; and public health research including epidemiology; exposure assessment and remediation; behavioral sciences; economic; and social policy research. The application must contain a minimum of three research projects, one of which must be CBPR project and one must be focused on mechanistic research.

Contact Person(s):
Gwen W. Collman; Phone: 919-541-4980; email: collman@niehs.nih.gov
Chris Saint; Phone: 202-564-9839; email: saint.chris@epa.gov

Applicable Catalog of Federal Domestic Assistance (CFDA) Number(s): 66.500, 93.113, 93.114, 93.115

Eligibility Information:
You may submit an application if your institution has any of the following characteristics: 1) Non-profit organizations, 2) Public or private institutions, such as universities, colleges, hospitals, and laboratories, 3) Units of State and local governments, 4) Eligible agencies of the Federal government, 5) Domestic institutions. See full announcement for more detailed information

Award Information:
Anticipated Type of Award: Center grant
Estimated Number of Awards: Up to six Center grants
Anticipated Funding Amount: Approximately $9 million
Potential Funding per Grant: Up to $1 million direct costs per year for up to 5 years

Sorting Codes(s):
The sorting code for applications submitted in response to this solicitation is ES-03-004

Deadline/Target Dates:
Letter of Intent Due Date: April 1, 2003
Application Proposal Due Date: May 16, 2003

PURPOSE

The National Institute of Environmental Health Sciences (NIEHS) and the U.S. Environmental Protection Agency (EPA) 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, NIEHS and EPA invite grant applications for Centers that will conduct multidisciplinary basic and applied research in combination with community-based research projects on environmental threats to children's health and translate those research findings to public policy, community needs, and information for the health care community and for the general public.

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. They will also actively pursue the translation and application of these findings by developing and implementing strategies that get this information out into the public health community. 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.
  • 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.
  • Develop fully coordinated programs that incorporate exposure assessment and health effects research with development and validation of risk management and health prevention strategies.
  • Encourage the translation and application of research findings to the prevention and clinical decision making arenas and give information to the communities and policy makers that most need it to protect children's health.
  • 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 a variety of health concerns in young 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 it relates to brain and other organ systems growth and development through young adulthood. Specifically, disease areas such as respiratory diseases, neurodevelopment and neurobehavior, childhood cancers, birth defects, and other conditions can be included for study.

This initiative builds upon a related Request for Applications (RFA), which resulted in creation in 1998 and 2002, of twelve Centers for Children's Environmental Health and Disease Prevention Research (see below). The prior RFAs emphasized similar research foci: respiratory disorders; growth and development; learning and behavior, including developmental disorders.

Recompetition of the existing program emphasizes the need for continued research in all of the above areas. This year's program expands the role of translational research and community outreach by incorporating aims that encourage the creation and implementation of strategies that will move the research from the experimental and population laboratory to the prevention and clinical decision making arenas and to the general public. Scientifically, the focus of the continuing program reemphasizes the importance of exploring the unique susceptibilities of children that put them at risk of developing illness in early life. These susceptibilities include, but are not limited to: genetic susceptibility, susceptibility due to poverty and poor nutritional status, and increased risk due to strained social and behavioral supports and inadequate access to medical care. Research emanating from these Centers should fill existing gaps in our understanding of the complex interactions between genes and the environment, including chemical, physical, biological, social, behavioral and nutritional factors in the development of common childhood diseases.

RESEARCH OBJECTIVES

Background

The current initiative continues NIEHS' and EPA's intent to foster advances in children's health by supporting innovative state of the art research on the health impacts of contact with environmental chemicals and other exposures in the course of children's daily lives. Both agencies are interested in reducing environmental risks to children and to reduce the societal burden of children's illness and developmental and behavioral 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 laboratory and population science while applying community-based participatory research (CBPR) strategies. 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. In this regard, it is required that each Center has a CBPR project which capitalizes on partnerships between researchers and community-based organizations, including local affiliates of organizations which advocate on behalf of childhood health concerns or represent environmental concerns in their communities. Each Center should create a structure to carry out research that 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.

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.

In this competitive round, we are adding a distinct activity to each center, the Community Outreach and Translation Core, the purpose of which is to develop, implement and evaluate strategies to translate and apply the scientific findings of the Center into information for the public, policy makers, and clinical professionals to use to protect the health of 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 subproject that includes research of a community-based participatory nature and to develop a Community Outreach and Translation Core in order to support the translation and application of this research in the community and in the policy and clinical arenas.

Objectives

The long-range goals of this program are twofold: to stimulate new and expand on existing research on the role of environmental exposures in the etiology and prevention of prevalent 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.

A spectrum of scientific approaches is expected to create a truly multidisciplinary working environment where experimental research can inform population-based research and vice versa. These disciplines would include: mechanistic research including pathophysiology of target-organ system; toxicological research; molecular and cellular sciences; clinical research; and public health research including epidemiology; exposure assessment and remediation; behavioral sciences; economic; and social policy research. The application must contain a minimum of three research projects, one of which must be CBPR project and one must a laboratory based scientific project focusing on mechanism. Other projects can be designed to be multidisciplinary or singular in scientific focus.

The following is the list of specific childhood health outcomes and disease areas that will be considered to be responsive, for purposes of the current RFA, to the research mission areas of EPA and NIEHS. These topics identify areas where research at the basic/applied interface is essential to potential development of new approaches that can be used for detection, prevention, treatment, and effective management of environmentally related childhood disorders.

Respiratory Diseases

Particulate and gaseous pollutants, volatile organic compounds and biological agents active in the environment when inspired, can lead to inflammation of the airways and development of a spectrum of respiratory and systemic disturbances and diseases. As these toxicants are present as ubiquitous mixtures in the environment, the components of which vary with geography and other factors, it is important to gain further insight into how these agents work singularly or collectively to produce respiratory disease in young children. The importance of exposures to these agents and their interaction with genetic and other susceptibility factors is the primary topic of interest for the development of research proposals for this competition. There is a continuing need to understand the mechanisms of respiratory disease in children, including asthma, chronic obstructive pulmonary diseases, and allergy associated with chemical and biological environmental exposures. Research continues to be needed to examine mechanisms of tissue damage, including that produced by reactive oxygen species generated as a result of exposure to environmental oxidants and the intrinsic and extrinsic factors that make certain subgroups of children susceptible to these effects. By virtue of their greater physical activity out-of-doors when pollution levels may be high, children may experience higher exposures to these hazards than adults. In response to such pollutant exposure, epithelial cells in the lung synthesize and release a variety of potent mediators that can contribute to a local inflammatory reaction and play a role in pathogenesis of respiratory disturbances. It is important to understand the basic mechanisms by which pollutants alter the inflammatory response in airways, resulting in airway hyperactivity, IgE antibody production, and asthma and the factors that modulate these responses in the population. It is equally important to address other mechanisms of lung dysfunction, including compromise of immunologic responsiveness and modulations of receptor signaling pathways. Studies that combine information about the biology of respiratory disease, individual and population-based susceptibility factors and effects of reducing environmental exposures in a prevention framework, are encouraged.

Childhood Neurodevelopment and Learning


Exposure to a number of common environmental contaminants, such as lead, polychlorinated biphenyls (PCBs), and mercury, may inhibit intellectual development in children and ultimately result in behavioral problems. For example, PCBs and their heat degradation products have long half-lives, cross the placenta, and are excreted in breast milk. Prenatal exposure to PCBs can cause significant developmental toxicities in animals. Children are more susceptible to PCB-induced toxic effects than adults, and these effects are more severe and influence more organ systems in children than in adults.

These effects may persist throughout a child's lifespan, while in an adult only a portion of the lifespan may be affected. Continued research on toxic effects associated with low-level developmental exposure to these contaminants is needed. Enhancing our understanding of the pathways by which these contaminants exert their toxic action may result in development of more effective interventions. Effects of intrauterine exposure to environmental hazards are of interest, including changes that occur in maternal biokinetics during pregnancy and determinants of placental transport and fetal accumulation of toxicants. Additional effort should also be focused on defining how such contaminants modify intellectual and behavioral development, especially in areas such as hyperactivity and learning disabilities. Alterations in cognitive and behavioral function due to exposure to such agents as metals, solvents, and pesticides have to date received little systematic attention. For the purposes of this RFA, neurobehavioral and behavioral disorders 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; antisocial conduct and other behavioral disorders. Research on specific delays and impairments in cognitive, fine and gross motor, sensory function, language development, self-regulation and control, and social participation is appropriate.

Organ System Development and Pathobiology

In utero or postnatal exposure to a variety of environmental agents can have a profound influence on initial growth and development of individual organ systems. For example, children susceptible to effects of air pollution have reduced lung development, leading to smaller lung capacity in adulthood; this difference may in turn have important ramifications for adult respiratory morbidity and mortality. Exposures to teratogenic chemicals during specific time periods during gestation are related to the occurrence of birth defects in particular organ systems under development during those windows. Parental exposure to organic solvents, agricultural chemicals, or heavy metals may increase the risk of having a child with a neural tube defect or heart defect. In utero and early life exposures to carcinogens may also increase a child's risk of developing cancer before adulthood. The timing of exposures and their cellular and molecular consequences should be carefully considered in research that seeks to understand the relationship between susceptibility factors, environmental exposures and risk of a variety of childhood cancers. Another area that merits research attention in both basic and applied science is sexual development. Endocrine-disrupting chemicals may affect a number of physiological processes, including onset of menses and puberty. Moreover, exposures during early windows of vulnerability may carry risks for later onset of adult diseases.

Exposures of Interest

The NIEHS and EPA 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 mercury, chromium, arsenic, and manganese; solvents; polycyclic aromatic hydrocarbons; indoor air pollutants such as environmental tobacco smoke, allergens, mold and outdoor air pollutants including particulates, diesel, and other chemical air toxics. Other factors that effect 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. As new biomarkers are being developed and exposures measured during pregnancy and other critical windows of development, the need to further understand the physiological and gene expression aspects of xenobiotic metabolism and clearance in mothers and their children is pressing. Research that addresses the interaction between social factors and physical environmental factors is also encouraged.

Sources of exposure are a critical piece of the puzzle when understanding the total environment of the child. The quantification of the exposures that contribute significantly to the body burden in the child hinge on a better understanding of the child's macro- and microenvironments. Places that the child spends time in and the amount of time in activities that increase contact with hazardous substances need continued attention as we quantify children's exposures. Locations such as day care and school facilities, environments including primary residence, extended family homes, and vehicles used for transportation are all places where children can be exposed to toxicants. Neighborhood sources of pollutants, such as Superfund sites, incinerators high volume traffic corridors should be included as important sources of exposures. Whether the child is an urban dweller, or is living in an agricultural environment, the development of strategies to reduce exposures to chemical, physical and biological agents is still needed. Understanding the interactions of children in all aspects of the built environment is important to this continued area of research. The concept of the built environment and its effects on human health were discussed in a recent workshop (see http://www.niehs.nih.gov/translat/hd/be-conf.htm exit EPA for meeting report). Access of children to a hazard-free built environment which might include healthy schools, community recreation facilities and renovated housing stock may be the focus of preventive strategies targeting child wellness and improved health as part of this program. For example, research that explores how the design of the built environment impacts on the health of children and communities by influencing physical activity patterns, air and water quality and social capital, would be appropriate.

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. All applicants must form a partnership with a community-based organization as defined above in Research Objectives section. The foundation of the CBPR should be strongly linked to the basic science research within the Center. 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 described below.

  • 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).

  • At a minimum, each Center application should include:

    • One laboratory based scientific research project focusing on mechanism, which may include pathophysiological organ system studies, toxicological research, molecular and cellular sciences, and/or clinical research.
    • One community-based participatory research project. This project can include etiologic health effects, exposure assessment or intervention/prevention research.
    • At least one other research project chosen from among the following disciplines: epidemiology, exposure assessment and remediation, behavioral sciences, economic, and social policy research. These projects can be designed to be multidisciplinary or singular in scientific focus.

The CBPR and mechanistic research projects should be clearly identified in the proposal. If more that one project in each of these areas is included in the proposal all should be clearly labeled.

Laboratory based research projects should include mechanistic studies of environmental agents that contribute to adverse health outcomes in children as well as research that 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 environmentally induced diseases or conditions in children. Population-based research that explores genetic susceptibility using methods that incorporate gene and environmental interactions while quantifying risk is highly encouraged.

Novel approaches to exposure assessment in exposed and affected children across the life span are critical areas for this initiative. Advances would include development of and enhancements to state-of-the-art approaches to direct and indirect measurements of exposure to toxic chemicals in children. 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 would be appropriate areas of research.

Research on behavioral factors that affect exposure and one's ability to reduce exposure are important components of the field of children's environmental health, as is research that characterizes the economic and social impact of children's illnesses on society. Evaluation of how scientific information about children's environmental health impacts policy, social change and changes in clinical and public health management of these diseases is also encouraged.

  • 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/or quality control aspects of exposure analysis activities.

    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 30-40 percent of its budget to these research projects, exclusive of the CBPR research, and facility cores that support such research.)

  • 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 link 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 of the disease or its associated functional deficits. CBPR should be placed within the appropriate public health context. For Centers addressing areas in which there remains a need to establish exposure-disease links, the CBPR project can be related to etiology or exposure assessment based upon 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 link to a community-based organization and specific involvement of community members in development, conduct, and interpretation of the research. NIEHS and EPA 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 CBPR project. However, involvement of a local health department will not substitute for the required community-based organization. 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 may devote 20-35 percent of its budget to one community-based participatory research project.)

  • Each Center must include a Community Outreach and Translation Core (COTC), the purpose of which is to develop, implement and evaluate strategies to translate and apply the scientific findings of the Center into information for the public, policy makers, and clinical professionals to use to protect the health of children. This core should include personnel from 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 illnesses, members of professional societies of health care professionals, and state and local health departments or medical service organizations. Examples of activities that could be conducted would be the creation of training materials for health professions, novels strategies for dissemination of research findings to the broad audience of stakeholders, and focus groups to assess community understanding of research results and plans for action. (It is anticipated that a Center will devote up to 10 percent of its budget to the COTC.)

  • Each Center must include an administrative core unit that 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 percent 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 up to 10 percent of its budget to an administrative core.)

  • To attract new investigators into children's environmental health research, each Center must partially support at least one newly recruited Center scientist. Up to $70,000 per year, direct cost, may be used for each newly recruited Center scientist to provide up to 75 percent 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 underrepresented 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 up to seven percent of its budget to recruitment of a new scientist.)

ENVIRONMENTAL JUSTICE

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.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Program Project Grant (P01) and the Environmental Protection Agency's (EPA) Office of Research and Development, STAR (Science to Achieve Results) program administered in accordance with 40 CFR Part 30 and 40. Responsibilities for the planning, direction, and execution of the proposed project will be solely that of the applicant. 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 Centers. Indirect costs incurred by including consortia or subcontracts in the application will not contribute to the $1 million cap in direct costs. 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 November 1, 2003.

FUNDS AVAILABLE

Although this solicitation is included in fiscal plans of NIEHS and EPA for FY 2004, support for these Center grants is contingent upon availability of funds for this purpose. It is anticipated that an estimated total of $9 million, including direct, and facilities and administrative (F&A) costs, will be available for the first year of the program, which will support up to six Centers in FY 2004. 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.

ELIGIBLE INSTITUTIONS

You may submit an application if your institution has any of the following characteristics:

  • Non-profit organizations. Applications will not be accepted from for-profit organizations; however, organization may establish subcontract arrangements with non-profit organizations.
  • Public or private institutions, such as universities, colleges, hospitals, and laboratories
  • Units of State and local governments
  • Eligible agencies of the Federal government
  • Domestic institutions. Applications will not be accepted from foreign institutions, however, foreign institutions may establish sub-contract arrangements with domestic applicant institutions.

Partnerships between researchers and members of community-based organizations, faith-based organizations and grass roots advocacy organizations that are concerned with children's health or environmental health concerns are required. Applications that do not include such partnerships will be returned as non-responsive.

New and competitive continuation applications from existing grantees in the Children's Environmental Health Centers program in their fifth year of support will be accepted for consideration under this RFA.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his or her institution to develop an application for support. Individuals from under represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH and EPA programs.

DESCRIPTION OF CURRENTLY FUNDED NETWORK OF CENTERS FOR CHILDREN'S ENVIRONMENTAL HEALTH AND DISEASE PREVENTION RESEARCH

In 1998 and 2000, NIEHS and EPA funded 12 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 effects of exposure to pesticides and other contaminants on growth, development, learning, and behavior in both agricultural and inner city settings. The most recently awarded centers focus on developmental disabilities such as autism and learning disabilities. More information about the existing program can be found at: http://www.niehs.nih.gov/dert/programs/translat/children/children.htm exit EPA.

THE EPA CHILDREN'S ENVIRONMENTAL HEALTH INITIATIVE

The EPA recognizes that children's environmental health issues are a top priority and must become a central focus of the agency's efforts. This RFA is a component of the EPA'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).
http://www.epa.gov/cgi-bin/claritgw?op-Display&document=clserv:Other:0140;&rank=4&template=epa.

SPECIAL REQUIREMENTS

Annual Meetings: Annual meetings, to be held in Washington, D.C. or Research Triangle Park, NC, are planned for the exchange of information among investigators. Applicants must budget travel costs associated with these meetings for the Principal Investigator and the director of each project and the COTC in their applications.

Information Exchange: In addition, 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.

Quality Assurance: EPA regulations as stated in 40 CFR30.54 require the inclusion of a Quality Assurance Statement for each individual project supported by a center and a Quality Management Plan for the overall center organization. Together these documents provide information on how quality processes or products will be assured in order to meet the EPA requirement that awards involving environmentally related measurements or data generation must have a quality system in place that complies with the requirements of ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs".

A Quality assurance Statements (QAS) must be submitted for each project proposed in any application submitted in response to this RFA. Each QAS should not exceed two pages. This Statement should, for each item listed below, present the required information, reference the specific page and paragraph number containing the information, or provide a justification as to why the item does not apply to the proposed research.

  1. Identify the individual who will be responsible for the quality assurance and quality control aspects of the research. (Quality assurance (QA) is an integrated system of management activities involving planning, implementation, documentation, assessment, and improvement to ensure that a process, or item is of the type and quality needed for the project. Quality control (QC) is the system of technical activities that measures the attributes and performance of a process, or item against defined standards, to verify that they meet the stated requirements.)

  2. 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. Also, 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.

  3. 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.

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

  5. 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.

  6. 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.

  7. 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.

Submission of a Quality Management Plan (QMP) is not required at the time of application. Successful Center EPA award recipients will also be required, as a condition of their EPA grant, to complete an overall Center QMP. This 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.
See: http://www.epa.gov/quality/qs-docs/r2-final.pdf

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

  • Direct your questions about scientific/research issues to:

    Gwen W. Collman, Ph.D.
    Scientific Program Administrator
    Chemical Exposures and Molecular Biology Branch
    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

Chris Saint, Ph.D.
Assistant Director
National Center for Environmental Research
U.S. Environmental Protection Agency (8723R)
1200 Pennsylvania Ave., NW
Washington, DC 20460
Telephone: 202-564-9839
Fax: 202-565-2448
E-mail: saint.chris@epa.gov

  • Direct your questions about peer review 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-30
    111 T. W. Alexander Drive
    Research Triangle Park, North Carolina 27709
    Telephone: 919-541-1307
    Fax: 919-541-2503
    E-mail: bass@niehs.nih.gov

  • Direct your questions about financial or grants management matters to:

    Ms. Laura Williams-Boyd
    Grants Management Specialist
    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: 919-541-7629
    Fax: 919-541-2860
    E-mail: williams7@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
E-mail: puzak.jack@epa.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of the proposed research
  • Name, address, and telephone number of the Principal Investigator
  • Names of other key personnel
  • Participating institutions
  • Number and title of this RFA

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 EPA and NIEHS staff to estimate potential review workload and to plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should 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-30
111 T. W. Alexander Drive
Research Triangle Park, North Carolina 27709
Telephone: 919-541-1307
Fax: 919-541-2503
E-mail: bass@niehs.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html exit EPA in an interactive format. For further assistance contact GrantsInfo, telephone (301) 435-0714, Email: GrantsInfo@nih.gov

SUPPLEMENTAL INSTRUCTIONS

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: (1) at least one individual laboratory based research project, (2) a community-based participatory research project, (3) at least one other research project (4) Community Outreach and Translation Core, (5) an administrative core, (6) at least one newly recruited Center scientists, and (7) one or more facility cores (if applicable). 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 multiproject 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.

USING THE RFA LABEL

The RFA label available in the PHS 398 (rev. 5/2001) 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 marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf exit EPA.

SENDING AN APPLICATION TO THE NIH

To simplify administration of this joint NIEHS/EPA 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 and all appendix materials (at least 5 copies) 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-30
111 T. W. Alexander Drive
79 T.W. Alexander Drive, 3rd Floor (express and courier service)
Research Triangle Park, North Carolina 27709
Telephone: 919-541-1307
Fax: 919-541-2503
E-mail: bass@niehs.nih.gov
If any colored photoplates are submitted, please provide a total of 10 copies with the Appendix material.

APPLICATION PROCESSING

Applications must be received on or before 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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks.

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.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness 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.
  • 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.
  • 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

The goals of NIH and EPA supported research are to advance our understanding of biological systems, improve the control of disease and enhance health.

In written comments, reviewers will be asked to discuss the following aspects of your applications in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals:

  • Significance
  • Approach
  • Innovation
  • Investigator
  • Environment

The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application.

OTHER REVIEW CRITERIA

Evaluation of applications will be based upon the following additional criteria:

A. Overall Center

Centers must include three or more research projects with a conceptual theme focusing on one or more of the thematic areas outlined in the RFA. There must be evidence of the potential for a meaningful interdisciplinary collaboration between all of the components of the program.

  • Evaluate the interdisciplinary nature of the proposed research activities, integration of the projects around an overarching theme, and plans to effectively pursue interdisciplinary research objectives.
  • Evaluate the plans for active participation of communities and other stakeholders in the conceptualization, planning, implementation, and handling and dissemination of research and findings whenever appropriate.
  • Evaluate the ability of the Center to translate and apply research findings to the prevention and clinical decision making arenas and to affected communities.

B. Research Projects

Reviewers will be asked to evaluate each research project using the criteria listed below. Reviewers are asked to judge the likelihood that the proposed research will have a substantial impact on the pursuit of the goals of this RFA as implied by the criteria below. Each criterion will be addressed and considered by the reviewers in assigning the overall score for each project:

(1) SIGNIFICANCE. Does this research address important research objectives related to children's environmental health? Will these studies lead to a better understanding of factors which make children susceptible to the effects of environmental hazards and how to protect them?

(2) APPROACH. Are the conceptual research framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative interdisciplinary approaches? Is there clear evidence of significant interdisciplinary interactions in the conception, design, and proposed implementation of the projects?

(3) INNOVATION. Does the science proposed challenge existing paradigms or develop new methods or technologies that will move the area of study forward? Does the research reflect sufficient originality, novelty, and innovation to make it highly relevant to the overall goals and objectives of Centers for Children's Environmental Health and Disease Prevention?

(4) INVESTIGATORS. Are all investigators appropriately qualified with demonstrated competence to conduct the proposed research? Is the proposed work appropriate to the experience level of the principal investigator and other project researchers? Are the proposed time commitments for all key researchers reasonable and appropriately associated with the project?

(5) ENVIRONMENT. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed projects take advantage of unique and interdisciplinary features in the scientific environment and reach out to useful collaborative arrangements? Is there evidence of adequate institutional support?

C. Community-based Participatory Research (CBPR)

In addition to review criteria for the other research projects, CBPR projects will be evaluated on:

  1. Demonstrate extent of community support and liaison. Rationale for selection of the targeted population and documentation of environmental health needs and risk factors. Evidence of access to, interaction with, and participation of community members and community leaders in development and conduct of the project. Establishment of collaborative interactions among all project participants. Extent to which the design demonstrates sensitivity to cultural and socioeconomic factors in the community. Demonstration of effective communication channels between researchers and community members. Plans for useful and practical dissemination of project activities and findings within the affected community(ies). Active involvement of at least one community based organization is a minimal requirement for responsiveness to this RFA.

  2. For intervention projects evaluate the extent to which findings can be translated into public health practice and/or policies. Are links to the community within which the research is framed well documented reflecting both appropriate levels of support and collaboration?

D. Facility Cores

  1. Evaluate overall use of each core by funded by proposed research projects. Determine whether projected use is sufficient to warrant
    establishment of the core.
  2. Evaluate the core for its overall importance to research activities in the Center.
  3. Evaluate whether there is sufficient institutional commitment to meet the requirements of the core.
  4. Determine if the requests for equipment, supplies, and other items are appropriate for the activity of each core.
  5. Evaluate the cost effectiveness and efficiency of use of the core in the context of the quality, breadth, and utility of service provided.
  6. Adequacy of qualifications and performance (if applicable) of core personnel to conduct high quality, reliable resource operations.

E. Administrative Core

  1. Evaluate whether the lines of authority and the administrative structure are designed for effective center management.
  2. Evaluate the qualifications, responsibilities, and effectiveness of senior leaders. Identify if the percent effort is appropriate.
  3. Evaluate the duties and percent efforts of administrative staff of the center in terms of their qualifications and contributions to the specialized needs and conduct of the center's research activities.
  4. Evaluate the effectiveness of the center's internal planning and evaluation activities. Determine who is involved and the mechanisms used. Determine if these activities are documented. Evaluate how well the administrative structure maximizes the Center's capability to take advantage of research opportunities.

F. Community Outreach and Translation Core (COTC)

  • Evaluate the appropriateness of the proposed core activities with regard to the potential for engaging community support for Center research projects, adequate dissemination of study findings, and translation of research findings to public health action.
  • Evaluate the expertise of core members to fulfill the mission of the COTC.

G. Institutional Commitment

  1. Evaluate the effectiveness of the Center as a formal organizational component within the institution relative to other organizational components. Determine whether the reporting, accountability, and management structure of the Center within the institution are equivalent to that of comparable organizations within the institution. Assess the adequacy of institutional procedures and plans for monitoring, evaluating, and assuming accountability for the general success of the CPHHD.
  2. Evaluate the specific resources provided by the institution such as personnel, appropriate facilities, financial support, and other forms of
    support that reflect the level of the institution's commitment to the functional stability, continuing development, and success of the Center.
  3. Appraise the adequacy of the institutional infrastructure for assessing progress and needs.

ADDITIONAL REVIEW CRITERIA

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.)

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.)

DATA SHARING: The adequacy of the proposed plan to share data.

BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.

RECEIPT AND REVIEW 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 announcement. Please contact the program official listed below regarding any changes in the schedule.

Letter of Intent Receipt Date: April 16, 2003
Application Receipt Date: May 16, 2003
Peer Review Date: August 2003
NAEHS Council/NCER Review Date: September 2003
Earliest Anticipated Start Date: November 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

  • Scientific merit (as determined by peer review).
  • Availability of funds.
  • Programmatic priorities.

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. Awards to 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.

REQUIRED FEDERAL CITATIONS

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH

It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating 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 AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October 2001," published in the NIH Guide for Grants and contracts on October 9, 2001 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html exit EPA; a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm exit EPA.
The amended policy incorporates: the use of NIH definition of clinical research: updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to be required for all NIH-defined Phase III clinical trials that:
a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

The NIH maintains a policy 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 (Type 1) 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 is available at http://grants.nih.gov/grants/funding/children/children.htm exit EPA.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html exit EPA.

PUBLIC ACCESS TO RESERACH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 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. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm exit EPA.

Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 exit EPA.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov exit EPA and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm exit EPA and Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. Awards by EPA are made under the authority of 40 CFR Part 30 and 40.

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm exit EPA.

The PHS and EPA strongly encourage all grant recipients to provide a smoke-free workplace and discourage the 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 PHS and EPA mission to protect and advance the physical and mental health of the American people.

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