CENTERS FOR CHILDREN'S ENVIRONMENTAL HEALTH AND DISEASE PREVENTION RESEARCH

RELEASE DATE:  January 28, 2003 (This RFA has been modified, see RFA-ES-05-004)
                                (See addendum NOT-ES-03-007)

RFA:  ES-03-004
 
National Institute of Environmental Health Sciences (NIEHS)
 (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

THIS RFA CONTAINS THE FOLLOWING INFORMATION:

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
 
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:
 
o 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.
 
o 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. 
  
o Develop fully coordinated programs that incorporate exposure assessment and 
health effects research with development and validation of risk management 
and health prevention strategies.

o 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. 
 
o 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 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.
 
o 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). 

o 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.  

o 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.)

o 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.)
 
o 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.)

o 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.)
 
o 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:

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

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:

o 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: 202-564-6909
Fax: 202-565-2448
E-mail: saint.chris@epa.gov
 
o 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

o 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:

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

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 (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

Five collated sets of color/glossy photographs should be included with the  
other 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.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.  

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:

o Receive a written critique.
o 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.
o 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:

o Significance 
o Approach
o Innovation
o Investigator
o 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.  

o 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.    

o 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.

o 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.

2. 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.

3. 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 funded by proposed research projects. 
Determine whether projected use is sufficient to warrant establishment of the 
core.  Evaluate the core for its overall importance to research activities in 
the Center.  Evaluate whether there is sufficient institutional commitment to 
meet the requirements of the core.

2. Determine if the requests for equipment, supplies, and other items are 
appropriate for the activity of each core.

3. Evaluate the cost effectiveness and efficiency of use of the core in the 
context of the quality, breadth, and utility of service provided.

4. 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)

o 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.  

o 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:

o Scientific merit (as determined by peer review).
o Availability of funds.
o 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; a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
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.

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

PUBLIC ACCESS TO RESEARCH 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

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.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance at 
http://www.cfda.gov 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 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

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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