NIH Guide: CENTERS FOR CHILDREN'S ENVIRONMENTAL HEALTH AND DISEASE PREVENTION RESEARCH

Full Text ES-97-004

CENTERS FOR CHILDREN'S ENVIRONMENTAL HEALTH AND DISEASE PREVENTION
RESEARCH

NIH Guide, Volume 26, Number 29, August 29, 1997

RFA: ES-97-004

P.T.

Keywords:

National Institute of Environmental Health Sciences
National Center for Environmental Research and Quality Assurance, U.S. Environmental Protection Agency

Letter of Intent Receipt Date: September 30, 1997
Application Receipt Date: January 21, 1998

PURPOSE

The National Institute of Environmental Health Sciences (NIEHS), the
Environmental Protection Agency (EPA) and the National Center for
Environmental Health, Centers for Disease Control and Prevention
(CDC), 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 develop
multidisciplinary basic and applied research in combination with
community-based prevention research projects to support studies on
the causes and mechanisms of children's disorders having an
environmental etiology, identify relevant environmental exposures,
intervene to reduce hazardous exposures and their adverse health
effects, and eventually decrease the prevalence, morbidity, and
mortality of environmentally related childhood diseases. The purpose
of awards in this program of Centers for Children's Environmental
Health and Disease Prevention Research is to:

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

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 childhood disease.

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

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.

The long-range goal of this program is 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.

Each application is to be designed around a central scientific theme,
specifically examining the role of environmental agents in one of
the following research foci: (1) children's respiratory disease; (2)
childhood learning; (3) growth and development (see Research Scope
below). A minimum of two (2) basic biomedical research projects and
one (1) community-based intervention research component must be
proposed within each Center (see Description of a Center below).

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
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 2000" (Full Report: Stock No. 017-001-00474-0 or
Summary Report: Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-512-1800).

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 agency's overall initiative that,
together with the efforts of partner agencies, will ensure that
children receive the protection they need and deserve and help our
nation fulfill its obligation to protect future generations.
Potential applicants may obtain a copy of the EPA's national agenda
to protect children's health from environmental threats (EPA 175-
F-96-001) from the EPA program contact listed under INQUIRIES.

ELIGIBILITY REQUIREMENTS

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

MECHANISM OF SUPPORT

The funding mechanisms to be used to assist the scientific community
in participating in this grant program will be those of: 1) the
National Institutes of Health (NIH) Specialized Center (P50); or 2)
the Environmental Protection Agency's Office of Research and
Development, administered in accordance with 40 CFR Part 30 and 40.
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. 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
August, 1998.

FUNDS AVAILABLE

Although this solicitation is included in fiscal plans of EPA and
NIEHS for FY 1998, support for these Center grants is contingent upon
availability of funds for this purpose. It is anticipated that an
estimated total of $10 million, including direct and indirect costs,
will be available for the first year of the program, which will
support up to six Centers in FY 1998. It is expected that NIEHS and
EPA may solicit additional new Specialized Center applications
through subsequent issuance of a similar RFA addressing children's
environmental health.

RESEARCH OBJECTIVES

Background

Establishment by NIEHS and EPA of Centers for Children's
Environmental Health and Disease Prevention Research recognizes the
unique vulnerability of children to hazardous environmental
exposures. The greater susceptibility of children to such exposures
is likely related to changes in organ system growth as well as
developmental and metabolic capacities that adjust during childhood.
For example, lung surface area increases tenfold and gas exchange
areas increases more than twenty-fold from birth to adulthood. Since
many xenobiotics are absorbed through the alveolar epithelium, the
lung represents a particularly sensitive organ. Moreover, the diets
of children and their unique behavioral patterns such as crawling and
hand-to-mouth activities augment the probability of certain
exposures.

In the past, standards regulating exposure to environmental health
threats have been, in some cases, based on research and assessment of
risks to adults. Often, the knowledge base to ensure that standards
are protective of infants and children has not been adequate.
Because children have very different metabolic, physiologic, and
developmental processes, diets, and exposure patterns than adults,
their health outcomes can differ drastically. There is a clear need
for additional research that can more fully incorporate children's
unique traits into risk assessment paradigms.

Environmentally related childhood diseases represent an enormous
public health problem. For example, asthma, the most common chronic
childhood illness, afflicts nearly five million children and is the
leading cause of children's emergency room use, hospital admission,
and school absences. From 1982 to 1993, the prevalence, morbidity,
and age-adjusted mortality rates for asthma increased significantly
despite improvements in asthma diagnosis and management and improved
understanding of the biology and immunology of the disease. The
mortality rate attributed to asthma for children five to fourteen
years of age has doubled since 1980 and is highest among African-
American children, who are three times more likely than Caucasian
children to die of this illness. Chronic asthma in children is
highly associated with chronic respiratory disease in adulthood and
has a huge health, societal, and economic impact.

Approximately 20% of the 76.7 million children in the United States
live in poverty. Children who live in these impoverished communities
are exposed to multiple indoor and outdoor environmental pollutants
at disproportionately high levels. Preambulatory and crawling
children spend significant time indoors and are subjected to high
levels of allergens found in carpeting, bedding, upholstered
furniture, and house dust. Indoor pollution levels may also depend
on heating sources, use of household chemicals, parental smoking
habits, and the presence of nearby industrial or waste facilities,
which may result in increased amounts of polycyclic aromatic
hydrocarbons, volatile organic compounds, and particulates. In
addition, it is estimated that 20-60% of children between one and
five years of age are exposed to unsafe levels of organophosphate
pesticides. Exposure to such agents may occur in both indoor living
space and outdoor play areas. There is thus a particular need to
address environmental health problems of children living in
socioeconomically disadvantaged or medically underserved communities.

The current initiative is intended to foster advancement in
children's health through enhancing our understanding of basic
disease mechanisms and promoting community-based prevention
activities related to children's respiratory disorders, childhood
learning, and growth and development. Collaborative,
multidisciplinary research approaches are required to explore the
dynamic interaction of children with their environment. This Center
program therefore emphasizes integration of basic laboratory science
with applied intervention strategies. Because the latter are also
research projects, it is important to note that each intervention
research project should include appropriate methodology for assessing
its effectiveness (see 'Description of a Center' below). Centers are
expected to have fully coordinated programs that incorporate exposure
assessment and health effects research with development and
validation of risk management and health prevention strategies.
Moreover, involvement of the affected community in planning,
implementing, and evaluating an intervention effort is essential.
Community-based prevention/intervention research 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.

Research Scope and Objectives

Centers for Children's Environmental Health and Disease Prevention
Research are research-based Center grants designed to support
interactive groups of research projects and core service facilities.
Research activities included in these Center grants must comprise, by
definition, a multidisciplinary approach to biomedical problems
addressing one or more of the specific research topic areas announced
in this RFA (see below).

A Center should identify a central theme or focus of its research
effort so that the subprojects involved are responsive to one or more
of the specific research areas of children's environmental health
supported by this grant program. Furthermore, the translational
objective of this program requires that one of the subprojects
consist of a community-based intervention.

The following is the list of specific research topics 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 and volatile organic compounds,
when inspired, can lead to inflammation of the airways and
development of a spectrum of respiratory and systemic disturbances
and diseases. This is especially true in the case of environmental
agents, or their metabolic products, which have the capacity to
access alveolar spaces and to diffuse or be transported into the
blood stream. Such compounds may then exert adverse health effects
at systemic target organs. The principal objective of research in
this focus area is to understand the mechanisms of respiratory
disease in children, including asthma, chronic obstructive pulmonary
diseases, and allergy associated with chemical and biological
environmental exposures. Additional research is needed to examine
mechanisms of tissue damage, including that produced by reactive
oxygen species generated as a result of exposure to environmental
oxidants. These oxidants include ozone, nitrogen dioxide, and
particulate matter. 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. It is equally important to
address other mechanisms of lung dysfunction, including compromise of
immunologic responsiveness and modulations of receptor signaling
pathways.

Childhood 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, research focusing exclusively on lead
poisoning in children will be considered nonresponsive.

Growth and Development

In utero or postnatal exposure to a variety of environmental agents
can have a profound influence on initial growth and development. One
such 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. 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. It is also important
to expand our understanding of the potential role of environmental
factors in the etiology of birth defects. Parental exposure to
organic solvents, agricultural chemicals, or heavy metals may
increase the risk of having a child with a neural tube defect.

For all of these research areas, attention should be given to
mechanistic studies of toxicity. It is also desirable that exposure
assessment research be included, where appropriate. Furthermore, it
is important to evaluate the contribution of genetic heterogeneity to
the disease process. Information on individual variability with
respect to chemical sensitivity and metabolism of xenobiotic agents
has a significant role in defining disease onset and progression.
Asthma susceptibility, for example, is known to run in families.
Identification of asthma susceptibility genes, which might interact
with environmental factors to contribute to the rising incidence of
this disease, would hold significant promise for designing new
prevention and treatment approaches.

Prospective applicants are strongly encouraged to discuss potential
program relevancy issues as well as application preparation with the
program staff contact cited under INQUIRIES in this RFA. Applicants
should note that the research scope of this RFA does not include any
long-term (longer than five years) studies.

Description of a Center

A Specialized Center provides the opportunity for investigators to
engage in interdisciplinary and collaborative research directed
toward a specific focus in children's environmental health. It is
required that each Center include community-based intervention
research as well as basic studies clearly related to a disease or
dysfunction. The foundation of the intervention should be strongly
linked to the basic science research. The basic science studies
should be driven by the needs of the intervention project. Thus, a
Center should have a central theme to which all research projects
pertain. In addition, a Center may include core units to provide
services to the various research projects and to support the
organizational and administrative aspects of the program.

Applications that include only basic or only intervention/ prevention
research will not be responsive to this RFA.

The minimal requirements for a Specialized Center of Research in
Children's Environmental Health are as follows:

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

Each Center will support at least two basic research projects that
thematically address one or more research areas listed under Research
Scope. Potential basic research projects should include mechanistic
studies of environmental agents which contribute to adverse health
outcomes in children. These may include: basic cellular and
molecular mechanisms of toxicity; pathophysiology; epidemiology; and
individual susceptibility. These basic research projects should be
linked to the intervention research project described below.
Interactions between investigators responsible for basic research and
intervention research projects are expected to strengthen the
research, enhance transfer of fundamental findings to an applied
setting, and identify new research directions. [It is anticipated
that a Center will devote 30-45% of its budget to basic research
projects.]

Each Center will support one project that develops, implements, and
evaluates a community-based intervention/prevention program.
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." 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 African, Hispanic, Asian, and Native
Americans. It is strongly encouraged that basic science projects be
in a similar scientific area as the intervention research project in
order to facilitate transfer of information from laboratory to the
community. This project may take the form of a primary, secondary,
or tertiary prevention. It is important to note that this 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; (d) measurement instruments and their
reliability and validity, considering both process and outcome
evaluation; (e) data management and analysis methods; (f)
identification and description of target community and known
environmental health hazards; (g) means of establishing effective
interaction and collaboration with community members. Because this
project is intended to be community-based, the application must
demonstrate a specific, existing linkage to a community-based
organization and specific involvement of community members in
development, conduct, and interpretation of the intervention. NIEHS,
EPA, and CDC recognize that local health departments often play an
important role in delivering public health services to the community.
Therefore, applicants are also encouraged to consider including
local, county, or state health departments in the proposed
intervention research project. However, involvement of a local
health department will not substitute for the required community-
based organization. Applications lacking a demonstrable linkage to a
community-based organization will be considered nonresponsive. [It is
anticipated that a Center will devote 20-30% of its budget to one
community-based intervention research project.]

Each Center may support facility cores that provide a technique,
service, or instrumentation that will enhance ongoing research
efforts. Examples of such facilities are animal resources,
cell/tissue culture, pathology, biostatistics, molecular biology,
analytical chemistry, exposure assessment, etc. 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
chargeback system. [It is anticipated that a Center will devote
10-20% of its budget to facility cores.]

An administrative core unit which provides 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 (3) to five (5) scientists,
having expertise appropriate for the Center's research focus, plus
one (1) representative from a community-based organization involved
in community-based intervention research. Representation from a
state or local health department is also encouraged. At least 67% of
Committee members should be from outside the grantee institution.
The membership of the advisory committee must be approved by the
funding agency. The function of this Committee is to assist in
evaluating the merit, value, and contribution of research projects;
the relevance and importance of individual organizational elements to
accomplishing the overall goals of the Center; and the effectiveness
of the newly recruited Center scientist program. [It is anticipated
that a Center will devote 10-15% of its budget to an administrative
core.]

To attract new investigators into children's environmental health
research, each Center is encouraged to partially support up to two
(2) newly recruited Center scientists. Up to $70,000 per year,
direct cost, may be used for each newly recruited Center scientist to
provide up to 75% salary support, technical support, equipment, and
supplies. The duration of support as a newly recruited scientist is
limited to two (2) 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 intervention 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 no more than
14% of its budget to recruitment of new scientists.]

SPECIAL REQUIREMENTS

Annual meetings, to be held in Washington, DC or Research Triangle
Park, NC, are planned for the exchange of information among
investigators. Applicants must budget travel costs associated with
these meetings in their applications.

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

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

The NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) requires that women and members of minority groups and their
subpopulations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear
and compelling rationale and justification is provided that inclusion
is inappropriate with respect to the health of the subjects or the
purpose of the research. This new policy supersedes and strengthens
the previous policies (Concerning the Inclusion of Women in Study
Populations, and Concerning the Inclusion of Minorities in Study
Populations), which have been in effect since 1990. The new policy
contains some provisions that are substantially different from the
1990 policies. Grantees, regardless of funding source, will be
expected to adhere to this policy.

All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994. Investigators also may obtain copies of the policy
from the program staff listed under INQUIRIES. Program staff may
also provide further discussion concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by September 30, 1997, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted. Although a letter of intent
is not required, is not binding, and does not enter into the review
of subsequent applications, the information that it contains allows
EPA and NIEHS staff to estimate potential review workload and to
avoid conflict of interest in the review.

The letter of intent is to be sent to:

Ethel Jackson, DDS,
Chief, Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-24
Research Triangle Park, NC 27709

APPLICATION PROCEDURES

Content of Applications

A response to this RFA should consist of an application that includes
a detailed description of a Specialized Center of Research in
Children's Environmental Health consisting of at least two individual
basic research projects, a community-based intervention research
project, an administrative core, up to two newly recruited Center
scientists, and, if applicable, one or more facility cores. The
proposed research plan should present the applicant's perception of
the Center's organization and component functions. This plan should
demonstrate the applicant's knowledge, ingenuity, practicality, and
commitment in organizing a 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.

The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these awards. Application kits are available at most
institutional offices of sponsored research or may be obtained from
the Division of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/710-0267, email:
ASKNIH@odrockm1.od.nih.gov.

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.

If IRB or IACUC review is unavoidably delayed beyond submission of
the application, a follow-up IRB certification and/or IACUC
verification from an official signing for the applicant organization
must be sent to and received by the Scientific Review Administrator
of the Special Emphasis Panel by March 2, 1998. If IRB certification
and/or IACUC verification is not received by March 2, 1998, the
application will be considered incomplete and returned to the
applicant.

The RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the application.
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, Centers for Children's
Environmental Health and Disease Prevention Research, and number, RFA
ES-97-004, must be typed on line 2 of the face page of the
application form and the YES box must be checked. 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:

DIVISION OF RESEARCH GRANTS
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, two additional copies of the application
must be sent to:

Ethel Jackson, DDS
Chief, Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-24
111 T.W. Alexander Drive, EC-24
Research Triangle Park, NC 27709
Research Triangle Park, NC 27709 (for express/courier service)

Applications must be received by January 21, 1998.

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: September 30, 1997 Application
Receipt Date: January 21, 1998
Initial Review Group Peer Review: March 1998
NAEHS Council/NCERQA Review: May 1998
Earliest Award Date: August 1, 1998

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and for responsiveness to the RFA by NIEHS and EPA Staff. Incomplete
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 intervention research subprojects.

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. This initial review
group will function according to PHS policy, utilizing the review
criteria stated below. As part of the initial merit review, a triage
process may be used in which applications will be determined to be
competitive or noncompetitive based on their scientific merit
relative to other applications received in response to this RFA.
Applications determined to be noncompetitive by the review committee
will be withdrawn from further consideration, and the principal
investigator will receive a summary statement reflecting the
reviewers' evaluation. Applications judged to be competitive will be
further discussed and assigned a priority score.

Applications recommended for funding will then receive a second level
review by both EPA's National Center for Environmental Research and
Quality Assurance (NCERQA) and NIEHS's National Advisory
Environmental Health Sciences Council (NAEHSC).

Review Criteria

Evaluation of applications will be based upon the following:

1. Research Plan

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

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

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

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

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

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

2. Personnel

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

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

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

3. Facilities and Management

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

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

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

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

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

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

4. Budgeting

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

AWARD CRITERIA

The anticipated date of award is August, 1998. Approved applications
will be considered for award based on scientific and technical merit;
program balance; and availability of funds. Funding will be provided
to each Center by a single award from either EPA or NIEHS or a
combination of two separate awards. Administrative and budgetary
policies of EPA and NIEHS will apply to these awards.

In order to receive funding, an individual domestic institution's
application for a Specialized Center grant must have three or more
related, interactive, and high quality research subprojects that
provide a multidisciplinary, yet thematic, approach to the problems
to be investigated. At least one of the subprojects must be a
community-based intervention. Awards will not be made for
applications with research activities focused exclusively on
intervention research or exclusively on basic research or for
applications or components thereof proposing long-term
epidemiological or large-scale clinical trial research.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

Allen Dearry, Ph.D.
Chemical Exposures and Molecular Biology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-21
Research Triangle Park, NC 27709
Telephone: 919/541-4500
FAX: 919/541-2843
Email: dearry@niehs.nih.gov

Christopher Saint, Ph.D.
Assistant Center Director
National Center for Environmental Research and Quality Assurance U.S.
Environmental Protection Agency
401 M Street, SW (8723R)
Washington, DC 20460
Telephone: 202/564-6909
FAX: 202/565-2448
Email: saint.chris@epamail.epa.gov

Direct inquiries regarding fiscal matters to:

Mr. David Mineo
Chief, Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Science
P.O. Box 12233, EC-22
Research Triangle Park, NC 27709
Telephone: 919/541-1373
FAX: 919/541-2860
Email: mineo@niehs.nih.gov

Mr. Jack Puzak
Deputy Director
National Center for Environmental Research and Quality Assurance U.S.
Environmental Protection Agency
401 M Street, SW (8701R)
Washington, DC 20460
Telephone: 202/564-6825
FAX: 202/565-2444
Email: puzak.jack@epamail.epa.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance Number 66.500, 93.113, 93.114 and 93.115. Awards by NIEHS
are made under authorization of the Public Health Service Act, Title
IV, Part A (Public Law 100-607) and administered under PHS grant
policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74.
EPA awards are made under the authority of 40 CFR Part 30 and 40.
The program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency
review.

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

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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