RELEASE DATE:  September 16, 2003

RFA Number:  RFA-ES-04-001

Department of Health and Human Services (DHHS)


National Institutes of Health (NIH)


National Institute of Environmental Health Sciences (NIEHS)
93.113; 93.115; 93.143



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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations


The mission of the National Institute of Environmental Health Sciences 
(NIEHS) is to promote research that will ultimately reduce the burden of 
human illness and dysfunction from environmental causes. Complementary to 
this mission are the goals of the national Superfund Program, established by 
Congress in 1980 to: identify uncontrolled hazardous wastes; characterize the 
impacts of hazardous waste sites and emergency releases on the surrounding 
environment (i.e., communities, ecological systems, and ambient air, soil, 
water); and, institute control or remediation approaches to minimize risk 
from exposure to these contaminants. With the 1980 passage of the 
Comprehensive Environmental Response, Compensation, and Liability Act 
(CERCLA), better known as Superfund, it soon became clear that the strategies 
for the cleanup of Superfund sites, and the technologies available to 
implement these cleanups, were inadequate to address the magnitude and 
complexity of the problem. 

In 1986, the NIEHS Hazardous Substances Basic Research and Training Program 
[the Superfund Basic Research Program (SBRP)] was created under the Superfund 
Amendments and Reauthorization Act (SARA). Congress, under SARA, authorized 
NIEHS to develop a university-based program of basic research and training 
grants to address the wide array of scientific uncertainties facing the 
national Superfund Program. The assignment of the SBRP to the NIEHS 
underscored an emphasis on human health effects, evaluation and prevention.  
However, the Program was mandated to support research that moved beyond the 
biomedical arena. Inclusion of non-traditional NIH research such as the 
modeling of fate and transport processes and the development of remediation 
technologies for environmental contaminants became part of a new paradigm for 
environmental health research. This paradigm supports the philosophy that the 
long-term improvement of public health will require the integration of 
biomedical, geological and engineering sciences to develop and apply a full 
range of primary prevention strategies. Therefore, the SBRP, supports 
coordinated multi-project, multidisciplinary university-based programs that 
link biomedical research with related engineering, hydrogeologic and ecologic 

The scientific parameters under which the SBRP operates were included in the 
SARA legislation, which mandates that the research funded by this Program 
should include development of (1) methods and technologies to detect 
hazardous substances in the environment; (2) advanced techniques for the 
detection, assessment, and evaluation of the effect on human health of 
hazardous substances; (3) methods to assess the risks to human health 
presented by hazardous substances; and (4) basic biological, chemical, and 
physical methods to reduce the amount and toxicity of hazardous substances.

Accordingly, NIEHS is proposing the continuation of the SBRP to address these 
mandates. Grants made under the SBRP will be for coordinated, multi-project, 
multi- and interdisciplinary programs. The objective remains to establish and 
maintain a unique Program that links and integrates biomedical research with 
related engineering, hydrogeologic, and ecologic components. 

In addition, the SBRP is committed to the concept that the Program is more 
than just a basic research program, and that to truly be effective it must 
foster the training of graduate and post doctoral students and be proactive 
in translating the scientific accomplishments emanating from the Program to 
its stakeholders  -- whether to the public through community outreach, to 
industry via technology transfer, or to government through partnerships. 
Therefore, NIEHS has included training, community outreach and the 
translation of research to appropriate audiences as components of this 

[NOTE: Within this document the use of the word "Program" with an uppercase 
"P" is used to denote the SBRP, whereas "program" with a lower case "p" 
denotes the research program of the individual applicant.]


The SBRP was created as a network of multidisciplinary, interdisciplinary 
teams of researchers to address the broad, complex health and environmental 
issues that arise from the multimedia nature of hazardous waste sites. 
Assembling researchers from diverse disciplines to focus on a unifying theme 
has provided the opportunity to advance the science in a more effective, 
efficient and resource-leveraged manner. Furthermore, establishing 
multidisciplinary research programs provided a more comprehensive 
understanding of complex environmental issues. The knowledge gained through 
these research efforts has proven useful in supporting the decisions made by 
state, local, and federal agencies, private organizations and industry 
related to the management of hazardous substances.  

In addition to supporting multidisciplinary, interdisciplinary research, the 
SBRP has considered community outreach, training of graduate students and 
post-doctoral candidates, and the translation and communication of its 
research findings to be important in realizing the full potential of the 

Presently, the Program funds 19 university-based grants, for a total of 234 
research projects and support cores 
( There are 70 collaborating 
universities and institutions associated with these 19 programs. This current 
solicitation marks the beginning of a new phase for the Program, that is, the 
change from a competition held once every five years for five-year awards, to 
an annual competition for up to five-year awards. The overall intent of this 
change is to enhance the ability of the SBRP to be more responsive to 
emerging issues by taking advantage of new and promising technologies as they 
arise to address the complexities associated with exposure to hazardous 
substances. This change will also provide the scientific community more 
opportunities to compete for SBRP funding and the ability to revise and 
resubmit applications in a timely fashion.  

Because the SBRP is a large continuing program, altering the competition 
cycle from once every five years to an annual competition is a complex 
undertaking. To implement this change in a logical and systematic manner will 
necessitate that there be a distribution of new and competing applications 
submitted over the next couple of years. Accordingly, half of the current 
programs will submit applications under this solicitation, and the remaining 
half of the programs will submit applications in the next year's 
solicitation. New applications will be accepted in both years.


The management of hazardous waste sites is one of the most challenging 
environmental issues facing the United States. Thousands of hazardous waste 
sites exist, including Superfund sites (considered the nation's most 
seriously contaminated sites), as a result of decades of industrial 
development, mining, manufacturing and military activities. Contamination of 
soils, sediments and groundwaters at these sites represents a significant 
potential threat to human and ecological health. In 1980, legislation was 
enacted (CERCLA) to address the cleanup of these sites. However, it became 
clear shortly thereafter, that the strategies for the cleanup of Superfund 
and hazardous waste sites, and the technologies available to implement these 
cleanups, were inadequate to address the magnitude and complexity of the 

Many factors contribute to the complexity of the problem faced at sites. 
Hazardous waste sites contain a large number of toxic chemicals such as 
polycyclic aromatic hydrocarbons (PAHs), other chlorinated organics and 
metals. Though there are examples where one or two contaminants may be found 
at a site, more often hundreds of different chemicals will be found at a 
single site, having known, and in many cases, unknown toxicities. Moreover, 
the physical, chemical and biological characteristics of soils, sediments or 
ground water at waste sites are important factors for understanding the 
chemical transformation and movement of hazardous substances through these 
environmental medias, and, ultimately, the potential for exposure to humans 
and ecosystems. Adding to the environmental complexities at a site, are the 
community issues, such as peoples concerns about health effects and the 
communication of hazards, both of which may impact the decision-making 
process. Furthermore, decisions necessary to develop effective cleanup plans 
at one site, may not be applicable to other sites, making the magnitude of 
the nations cleanup effort even more difficult. With this realization, 
Congress in 1986 with the passage of SARA, established the SBRP as a 
university-based grants program at NIEHS, an institute of the NIH, to develop 
a basic research and training program that complements the activities 
undertaken by the U.S. Environmental Protection Agency (EPA,, the principal manager of the 
Superfund Program and the Agency for Toxic Substances and Disease Registry 
To ensure that the SBRP meets the programmatic goals of the national 
Superfund Program and complements the needs of EPA and ATSDR, the research 
investment made by the SBRP must be "accountable", that is the research 
supported by the Program must provide a fundamentally sound science base for 
sister Superfund Program's "applied" objectives. For example, although the 
biomedical research conducted within the SBRP is not inherently different 
from biomedical research supported by other NIEHS programs, its uniqueness is 
the fact that the research should lead to its application in the risk 
assessment process, and, therefore, is "accountable."  Likewise, the non-
biomedical (e.g., hydrogeology, geochemistry, engineering, ecology, etc.) 
research is unique to the NIEHS. There are no other NIH or NIEHS programs 
that support these sciences in the context of improving site 
characterizations and providing informed cleanup decisions. Therefore, the 
integration of biomedical, geochemical and engineering knowledge acquired 
through the Program provides "accountability", and should advance both the 
understanding of the human and ecological risks from hazardous substances, as 
well as the development of new environmental technologies for the 
characterization and cleanup of sites. Consequently, more informed risk 
assessment and remediation decisions could be achieved, resulting in lower 
cleanup costs and the development of a range of primary prevention strategies 
for improving public health, ecosystems and the environment. 

A conceptual framework that has guided the SBRP is one that encompasses a 
holistic approach to environmental health sciences and basic research, i.e., 
the long-term improvement of public health requires an interdisciplinary 
approach that integrates biomedical, geochemical and engineering sciences.  
Decisions that are needed to protect human health, ecosystems and the 
environment must be based on mechanistic knowledge gained from the 
integration of available data from all relevant research disciplines such as 
toxicology, molecular biology, epidemiology, geology, ecology and 

For example, it is important to understand the consequences of exposure to 
environmental agents on human health and the relationship between exposure 
and disease outcome, as well as the effect of exposures on ecosystem 
dynamics. From a scientific perspective, a holistic approach involves 
contributions from all research disciplines. For example, identifying 
chemical contaminants; assessing properties that may affect transport and 
bioavailability of contaminants; and determining the critical pathways that 
result in exposures to human populations or ecosystems requires incorporating 
tools and approaches utilized by engineering, geochemical, biomedical and 
ecologic specialties. Understanding the potential health consequences 
involves not only assessing the levels and timing of exposure and whether the 
substance has reached a target organ or cell, but also determining whether 
contaminant exposure results in changes in normal physiologic processes, 
which could lead to disease or dysfunction or changes in 
biodiversity/ecological succession. Identifying the intrinsic (e.g., genetic) 
and host (e.g., nutrition, health, lifestyle habits) factors that may lead to 
enhanced sensitivity or resistance in a subset of the population are 
important considerations in developing human and ecological risk assessments.   

Prevention strategies to minimize exposures that could affect human or 
ecosystem health require the development and application of appropriate 
remediation technologies. While remediation strategies and technologies have 
been approved for cleanup at many Superfund sites, questions remain as to the 
effectiveness and appropriateness of these technologies for the long term.  
Moreover, remediation methods that are appropriate for one site may be 
inappropriate for other sites. Therefore, fundamental research focused on 
site characterization is important. Site characterizations influence the 
selection and application of a remediation strategy. Elucidating the 
biological, chemical and physical characteristics of a site and integrating 
this knowledge with an understanding of the molecular, physical or chemical 
processes involved in various remediation strategies will provide 
opportunities for the continued development of newer and more effective 
remediation approaches that will enhance our ability to protect human health 
and ecosystems. An emerging issue that may arise from the use of new 
remediation strategies is the potential of unforeseen adverse effects on 
ecosystems, human health and the environment. This complexity emphasizes the 
importance for interactions among engineers, toxicologists and other health 
and wildlife specialists. 

Clearly integration from many different disciplines will be needed to address 
these complex, interdependent yet fundamental issues. The relationships among 
these issues are difficult to address.  However, with the rapidly emerging 
development of new and sensitive methodological tools, some of these 
interactions are being defined with increased precision and sophistication.  
Continued development of exposure models, remediation methods, development 
and validation of biomarkers of exposure, effect and susceptibility based on 
mechanistic data, and the application of these to epidemiological and 
ecological studies will be important for risk assessment and in the decision 
making process for developing better and more effective remediation and/or 
containment strategies.  

Research goals and objectives

As the legacy of human activity continues to expand, biomedical research and 
environmental and engineering sciences must act in close partnership to 
address the complex environmental challenges of the future. For the past 16 
years, the NIEHS has encouraged and fostered partnerships among the diverse 
disciplines of science by creating, through the SBRP, multi-project, 
multidisciplinary programs each of which is focused on a central theme. 
However, until recently, strong interdisciplinary research, which brings 
different scientific disciplines together to study a common hypothesis, has 
been hampered by limitations in technologies. Technological advances such as 
"omics" technologies (genomics, proteomics, metabonomics, etc.); molecular, 
cellular and whole animal imaging methodologies; miniaturized 
tools/technologies (i.e., at the micro and nano-level); and improved cyber-
infrastructure and bioinformatic tools to gather, assimilate and interrogate 
large diverse datasets, have the capacity to stimulate interdisciplinary 

Thus, the goals and objectives of this RFA are to encourage the use of 
technological advances, as appropriate, to support multi-project, 
interdisciplinary research programs. The intent of applying these 
technologies is to enhance risk assessment and remediation decisions by 
improving our understanding of the health and environmental consequences 
associated with contaminants found at hazardous waste sites, and to develop 
improved strategies and technologies for cleaning up these sites. It is 
expected that each interdisciplinary research program will develop an overall 
conceptual theme that fosters collaborative interactions, whereby projects 
are integrated, and specific emphasis is placed on interactions between the 
biomedical and non-biomedical research projects. Such interactions promote 
synergistic knowledge, which has the potential to: (1) improve our 
understanding of the relationship between exposure and disease; (2) promote 
the development of a range of primary prevention strategies, (3) translate 
into lower cleanup costs, and (4) allow for the refinement of human and 
ecological risk assessments. All are important goals of the SBRP.

As stated previously, the NIEHS considers research supported by the SBRP to 
be an accountable enterprise. This accountability derives from the 
supposition that the evolution and maturation of hypothesis-driven basic 
research leads to increased opportunities for the translation of results into 
applied, "product-oriented" research directions. It is this evolution 
combined with the integration of biomedical and non-biomedical research 
within a thematic framework that allows for environmental synthesis and its 
application to real-life problems facing the nation's cleanup efforts. The 
knowledge gained through these efforts, ultimately, should reduce the burden 
of human illness and dysfunction from environmental causes. Therefore, the 
scientific themes and the research topics included in research proposals 
submitted by applicants should be cognizant of, and reflect the mandates and 
goals of the SBRP.
A central premise of the SBRP is that there is a link between chemical 
exposure and disease outcome, and that understanding/identifying this link 
will help to establish new or improved prevention/intervention modalities.  
Therefore, the Program's approach emphasizes basic and applied research, 
using state-of-the-art techniques, to improve the sensitivity and specificity 
for detecting adverse effects in humans or in ecosystems exposed to hazardous 
substances. In addition, the Program emphasizes understanding the phenomena 
that affect transport, fate and transformation of hazardous substances, and 
developing remediation strategies that attenuate and mitigate exposure as 
necessary to protect human and ecological health.

The scientific topics that are appropriate for this RFA to meet the goals and 
the objectives of the Program basically cover almost all aspects of 
scientific and intellectual inquiry and methodology that are directly related 
to understanding the relationship between exposure to hazardous substances 
and human health, impacts of hazardous substances on ecosystems, and 
strategies to understand the physical, chemical and biological processes 
affecting chemicals in environmental media as well as methods and approaches 
to effectively reduce the amount and toxicity of hazardous substances. 
However, for the purposes of the RFA, this research must be in context of the 
chemicals considered appropriate for study. These include:

o Hazardous substances found with some frequency at Superfund sites.
o Hazardous breakdown products of such substances formed in environmental 
media by physical, chemical or biological (e.g., plants, microorganisms, 
etc.) processes.
o Hazardous metabolites of the above substances or their breakdown products 
formed in humans or experimental animals.
o Chemicals with structural similarity to hazardous substances found at 
Superfund sites.

Note also that the applicant may refer to these Web sites to obtain 
information on hazardous substances that are relevant to Superfund and to 

Rather than provide detailed lists of research topics and approaches that are 
appropriate for study, examples of broad scientific themes relevant to the 
SBRP will be discussed. These thematic examples are meant to stimulate the 
thinking of potential applicants by illustrating interdisciplinary linkages 
between scientific disciplines, and, ultimately, how this knowledge enhances 
public and environmental health. These examples are not intended to be 
exhaustive, and investigators may study these and many other topics that meet 
the objectives of the RFA. The applicant is also directed to the following 
site ( ) for additional 
research topics and approaches of interest to the SBRP. 

Mechanism-based Research

Understanding the mechanisms whereby toxicants induce adverse health effects 
is at the heart of the SBRP. It is believed that the environment plays a 
contributing role in the etiology of most human diseases/dysfunctions (e.g., 
reproductive, immune competence, pulmonary/cardiovascular, cancer, 
neurodevelopment, neurobehavioral, renal, etc.). Therefore, research is 
needed that attempts to explain biologically complex systems in the context 
of exposure to environmentally relevant concentrations of hazardous 
substances and health outcome, by simplifying to a level where the problem is 
tractable. This typically results in moving from whole animal and organ-level 
biology to the powerful "cellular" and "molecular" approaches, and as these 
processes are understood by applying them back to whole animal and organ-
level research. 

An important consequence of supporting basic research to determine the 
underlying mechanism(s) responsible for environmentally induced diseases, is 
the identification of biomarkers – key molecular or cellular events that link 
a specific environmental exposure to a health outcome. The SBRP has a long-
standing commitment to supporting research focused on the development, 
validation and application of biomarkers for use in population-based studies.  
It is believed that as biomarkers become validated they will be invaluable in 
the prevention, early detection and early treatment of disease. 

Therefore, the SBRP seeks to support mechanistic research that includes 
laboratory-based studies unraveling disease pathways at the molecular and 
cellular level to the organ and whole animal level, as well as human-based 
and ecosystem-based mechanistic studies. The development and validation of 
biomarkers and their application in human and ecological studies is also 
encouraged. In addition to traditional methodological approaches, the use of 
state-of-the-art technologies and their integration should be considered as 
applicable. Examples include:

o Micro/nano –arrays
o "Omics" approaches (genomics, proteomics, metabonomics, etc.)
o Imaging technologies (molecular, cellular, etc.)

At another level, knowledge accumulated through the more traditional 
analytical reductionist framework primarily used within the SBRP, has 
provided useful systematic descriptions of biological systems. However, the 
limitations of this reductionist approach in gaining a deep understanding of 
physiologic conditions and diseases associated with chemical exposure are 
becoming apparent. For example, even when using current state-of-the-art 
molecular approaches there remains an inability to appraise 'biological 
noise'. This inability leads to focusing on a few genes, transcripts and 
proteins subject to major detectable changes, rather than small fluctuations 
that may be major determinants of the behavior of biological systems. 
Accordingly, the SBRP seeks to support research that surmounts these 
difficulties by encouraging a new, "integrative" biology. 

This "integrative" or systems level approach seeks to understand the 
structure and dynamics of regulatory networks within biological systems to 
better understand the mechanistic underpinnings of disease risk. Systems 
biology involves the creation of "virtual" (in silico) models of biological 
systems that are grounded in a molecular-level understanding to define and 
study the structure and dynamics of biological processes. Research is 
encouraged to develop new approaches to bring together existing data from 
experimental approaches (e.g., genetics, genomics, proteomics, metabonomics) 
and to integrate the data with hypotheses using mathematical and 
computational approaches. This may include building models through an 
iterative process of observation, modeling, hypothesis formulation or 
knowledge discovery and simulation-based analysis and verification. It is 
anticipated that deciphering functional genomics within an organismal context 
for systems biology will rely heavily on transgenics and genetics utilizing 
genetic models to achieve knowledge. 

Susceptibility and Predisposition Research

A critical confounding factor underlying the physiological consequences of 
exposure to hazardous substances is susceptibility. Susceptible populations 
may be defined as having unique characteristics that make them more sensitive 
to the effects of exposures to contaminants or other external insults. The 
Program recognizes the importance of identifying susceptible populations in 
order to reduce their burden of environmentally induced diseases. To address 
this issue, the SBRP seeks to support research focused on understanding the 
influence of intrinsic factors (e.g., genetic polymorphisms, haplotypes, 
gender and age), host factors (e.g., nutrition, health, lifestyle habits), 
and timing of exposure on cellular functions (e.g., metabolic capacity, 
repair of DNA damage, cell proliferation and apoptosis) critical to altering 
susceptibility and predisposition to disease. Not only is enhanced 
susceptibility an issue, but also understanding factors that contribute to an 
individual's resistance to effects of exposure are important considerations. 
The knowledge gained from understanding the interrelationships of factors in 
affecting host susceptibility and resistance will be key to reducing 
uncertainties in risk assessments and protecting health for the most 
vulnerable populations.

Translating these research findings and adapting appropriate molecular tools 
for use by epidemiologists in the conduct of population-based research is 
also a high research priority for the SBRP and is encouraged. Integration of 
these approaches into population-based studies has the potential to enhance 
the power to observe associations between exposure and health, or cause and 
effect relationships. The management, analysis and interpretation of complex 
and diverse data sets that emerge from these studies will require the 
development of new biostatistical approaches and mathematical algorithms to 
understand gene-environment, gene-gene or multi-gene-environment 
interactions. This will necessitate the collaborative efforts of biologists, 
epidemiologists, statisticians, systems engineers, computer scientists and 
others for integrating the available information from animal and human 
studies in such a manner that would inform the risk assessment process.  

Exposure Assessment Research

A priori, an environmentally induced disease implies that exposure has 
occurred within some temporal, spatial framework in relation to the 
appearance of disease. As such, there should be a direct link between 
exposure and disease morbidity and mortality. Unfortunately, as important as 
exposure is to the disease paradigm, it is one of the most difficult 
parameters to measure. Because exposure assessment is so integral to 
decisions related to protecting human health and ecosystems, understanding 
the complexities that impact the exposure component is an important research 
focus for the SBRP. One of the factors that contributes to this complexity is 
site characterization. Site characterization is an integral component of the 
exposure assessment paradigm because of the potential for humans and 
ecosystems to be exposed to contaminants at hazardous waste sites.  
Therefore, it is critical to understand the nature of contaminants found at a 
site, the potential for transformation and migration, and eventual uptake by 
humans and wildlife. 

The SBRP seeks to support research that improves site characterization so 
that the knowledge gained can be incorporated into the exposure assessment 
paradigm. Examples of research topics include methods to (1) identify and 
quantify chemical forms of the contaminants; (2) determine the toxicity of 
the contaminants, the concentrations of contaminants, the location of 
contaminants within a site, the ability of the contaminants to be chemically 
or biologically transformed; and (3) assess the physical, chemical and 
biological factors that affect movement of these contaminants from the site. 
Application of new and advanced technologies to develop biosensors, self-
contained miniaturized toxicity-screening kits and miniaturized analytical 
probes and data analysis tools that allow for real-time, on site monitoring, 
is also encouraged. The resulting data can then be placed in context of how 
contaminants affect nearby populations -- human or wildlife.  

Another factor that interacts directly with both exposure assessment and site 
characterization is bioavailability. Bioavailability of a contaminant 
describes the degree to which it is available for transformation, and 
transport within environmental medias (i.e., soil, sediments and surface and 
ground water) as well as the degree by which a contaminant eventually is 
assimilated by organisms. As an integrating principle, bioavailability 
crosses all scientific disciplines and is an important factor to consider in 
understanding the fate and transport of hazardous substances; the ability of 
hazardous substances to be internalized by microbes, wildlife and humans; and 
the ability once internalized to be available to tissues and organs. 
Accordingly, the SBRP considers research in these areas to be appropriate and 
of interest.  

The integration of available data from site characterization and 
bioavailability studies into exposure and risk assessment models provides a 
means to predict potential exposure levels in human populations and 
ecosystems. The validation of these models requires the development and 
application of new methods and technologies that can measure the extent of 
exposure in these disparate populations. Many approaches are available that 
have the requisite sensitivity and specificity to detect current exposures, 
or measure contaminants that have a long half-life in biological systems. 
However, the issues of past exposures and exposure to mixtures are still 
intractable problems. For example, rarely is one exposed to a single 
chemical, but rather is exposed either concurrently or sequentially by 
various routes of exposure, to a large number of chemicals over varying 
periods of time. Moreover, the concentrations of contaminants found in the 
environment and in living systems may be at very low levels. Therefore, 
research activities of interest for the SBRP are the development of improved 
technological methods and computational approaches to study temporal and 
spatial factors associated with timing of exposure, and to detect and assess 
exposure history within the context of biological relevancy. For example, 
research that applies advances in miniaturization technology may provide a 
unique opportunity to redefine exposure assessment by improving visualization 
tools, detection methods (such as biosensors), analytical tools, and data 
mining/data analysis tools that can be used for both environmental media and 
living biological systems. Research to develop mathematical, computational 
and statistical techniques that integrate this information into a holistic 
model for exposure and risk assessment is also encouraged.  

Remediation Research

The SBRP has a unique function within the NIEHS, in that research is 
supported that goes beyond the biomedical arena. One area where this is quite 
evident is in the support of the application of engineering sciences as a 
primary prevention strategy to improve human health by mitigating exposure 
and reducing toxicity of environmental contaminants at hazardous waste sites 
through remediation. At one level, it is important to understand the 
scientific principles and underlying processes necessary to clean up 
persistent toxics in groundwaters, sediments and soils. At another level, the 
translation of these basic principles into efficient and cost-effective 
technologies is equally important. By supporting this continuum of research 
from basic to applied approaches, preventing exposure and mitigating risk 
from exposure becomes a realistic goal.

Accordingly, the SBRP encourages the development of innovative physical, 
chemical and biological technologies for remediating hazardous substances 
found at waste sites. For example, the SBRP has had a long-term investment in 
basic research focused on the mechanistic basis for degradation and 
sequestration of contaminants by microbial, as well as other biological 
systems. The relationships between the number and type of species found at a 
site, the environmental contaminants, the nutrient requirements and other 
factors need to be considered in developing efficient bioremediation 
strategies. The use of modern molecular biology tools as well as biochemical, 
cellular or engineering approaches to enhance our understanding of the basic 
structural and functional properties of microbial and other populations 
involved in the bioremediation of hazardous substances is encouraged. 

Hazardous waste sites and Superfund sites very rarely contain a single 
contaminant but rather represent a complex mixture of many chemical classes 
at sites that may have varied physical, hydrogeochemical, or biogeochemical 
properties. These complexities may make the use of a single remediation 
strategy less effective. Research that integrates and applies mixed 
technologies may represent tractable approaches and is encouraged.  
Furthermore, advanced technologies, for example, nanotechnology and bio-
engineered plants, worms and microbes, provide new opportunities for 
remediation research. However, the introduction of these new tools into the 
environment may present their own hazards. Research that simultaneously seeks 
to understand the impact and potential toxicity of introducing innovative 
approaches into the environment is a new area of research ripe for 

Ecosystems Research

Understanding the ecological impacts from hazardous waste sites is a complex 
problem, in part, due to the number of species involved and their 
interdependencies. There is little baseline data describing all the 
components that reside within an ecosystem. Likewise, there is limited data 
available on the effect of various exposure scenarios on the different levels 
of ecosystem complexity, ranging from individual species, population levels, 
through ultimately the ecosystem level. Without these baseline data, it 
becomes extremely difficult to assess whether perturbations of the 
environment resulting from remediation efforts cause additional harm to the 
health of the ecosystem beyond that introduced by the original contaminants.  
In another vein, traditional ecosystem research has been done in isolation of 
human studies and has borrowed minimally from the advances made in this 
arena. Moreover, the dynamics between these two domains has not been fully 

To address these issues as well as others, the SBRP seeks to support research 
at the interface of biology, ecology, microbiology, bioengineering and 
engineering sciences. Research that may be directly applicable to the use of 
ecosystems as natural experiments to model the consequences of 
bioavailability and sequestration of contaminants is an area ripe for 
exploration. For example, if sequestration of contaminants at a site is an 
acceptable remediation strategy, what are the potential exposure consequences 
over time as aging and weathering occurs? Ecosystem research is also a 
valuable tool for understanding exposure assessment by evaluating 
bioavailability/bioconcentration of contaminants in the food web as a basis 
for predicting bioavailability/bioconcentration in humans.  

Ecological research would benefit tremendously by the continued application 
of state-of-the-art methods that have been primarily applied to human 
studies. For example, the development of informative "biomarkers" that 
identify stressors, key "sentinel" species and define the linkages between 
ecological genetics, stress responses within the ecosystem could draw from 
advances made in human biomarker studies. The SBRP encourages the application 
of "omics" tools, new sensor technologies and informatics with the goal of 
enhancing our understanding of ecological succession and biodiversity as a 
function of exposure to contaminants. These approaches may also provide a 
surrogate strategy for understanding potential human health effects.  


A critical issue related to hazardous waste sites for remediation or health 
effects research is that the concentrations at which chemicals occur in the 
environment are extremely low and exposures are long-term, continual, with 
simultaneous exposure to multiple chemicals. Whether one considers 
remediation strategies, exposure to humans or ecosystems, site 
characterization, bioavailability or the development of risk assessment 
models, chemical mixtures are an issue of concern. Biomedical research, 
exposure assessments or remediation strategies based on exposures to single 
substances in isolation is rarely reflected in real-life scenarios. This 
over-simplification fails to consider (1) prior exposure history and 
vulnerability (i.e., susceptibility); (2) interactions from other stressors 
of similar/dissimilar mechanisms of action; (3) potentiation or sensitization 
by chemicals not toxic in themselves; and (4) interactions of chemicals that 
could lead to synergistic or antagonistic effects.  

The SBRP seeks to support research that considers the effects of mixtures.  
With the continued development and refinement in the available repertoire of 
advanced tools and approaches, the scientific community may be in a better 
position to assess the impact of mixtures on all areas of research important 
to the SBRP. When considering research approaches for mixtures it will be 
critical to apply the latest technologies and mathematical approaches to 
investigate those biological effects that are subtle in nature and likely to 
escape immediate notice when using traditional approaches. The synthesis of 
diverse datasets to enhance our knowledge base for mixtures will be necessary 
to meet the challenges faced by researchers, environmental policy-makers and 
public health officials in designing and implementing strategies to reduce 
human disease and effects on ecosystems arising from exposure to mixtures. 

Risk Assessment  

The goal for every hazardous waste site cleanup is to protect the public's 
health and the environment. The risk assessment process helps to define 
exposures of concern and potential threats. The more robust the risk 
assessment, the better one is able to contribute to cost effective and yet 
protective choices. The synthesis of environmental knowledge resulting from 
SBRP conducted research ultimately should contribute to the robustness of the 
risk assessment process. Scientific inquiry that develops a paradigm whereby 
knowledge gained through understanding ecological effects resulting from 
hazardous waste sites furthers our understanding of potential human health 
effects, provides a creative, holistic approach to integrate seemingly 
separate ecological and human health risk assessments into more comprehensive 
site models. However, to fully realize the benefits from SBRP conducted 
research, especially as it pertains to issues of susceptible populations, low 
dose effects, mixtures and ecological studies, a new generation of risk 
assessment models will be required. 

With the advent of the "omics" technologies, development and application of 
bioinformatic tools to gather, assimilate and interrogate large diverse 
datasets will be a necessity to fully take advantage of the knowledge that 
may be gained from these approaches. How this information is used within the 
current risk assessment paradigm is an issue for further study. In addition, 
bioinformatic methods are needed for the integration and interpretation of 
information obtained, not only by the different "omic" technologies, but also 
across scientific disciplines. This approach will provide the tools necessary 
to synergize interdisciplinary research and enhance environmental knowledge 
useful for risk assessment.

Therefore, the SBRP is interested in innovative research to develop new risk 
assessment models that incorporate these issues. In addition, the development 
of new bioinformatic approaches to bridge data from different disciplines is 
needed. For example, multi-dimensional models are needed to describe risk 
from the source of contamination, through the movement of contaminants within 
environmental media, to its uptake by biological receptors (i.e., human or 
wildlife) and the effect within biological receptors on complex cellular and 
molecular pathways to the incipience of dysfunction or disease. This will 
require more detailed datasets and more sophisticated methods for their 
interpretation and mathematical algorithms for their modeling. Moreover, as 
analytical detection methods improve, risk assessment models must be able to 
better characterize the lowest dose-response effects that are biologically 
relevant. This will require more sophisticated statistical and computational 
methodologies and improved mathematical algorithms for predictive and 
computational toxicology. In addition, the SBRP encourages anticipatory 
research and identification of "emerging" issues, especially in identifying 
pivotal sources of uncertainty that might affect risk estimates. 


Although novel, innovative, cutting-edge research projects are the nucleus of 
an SBRP grant, it is the intent of the SBRP that the research activities be 
integrated into an interdisciplinary program. In support of this goal, NIEHS 
requires the establishment of cores.  Each grant application is required to 
have an Administrative Core, a Research Translation Core, and at least one 
Research Support Core. Outreach and Training Cores may also be included in 
support of achieving a truly multidisciplinary approach to hazardous 
substances research.

Administrative Core

The Administrative Core is a required component of a program. This Core 
provides the Principal Investigator a vehicle for overseeing the following:

o Planning and Coordination of Research Activities
o Integrating Cross-Discipline Research
o Overseeing Fiscal and Resource Management 
o Maintaining Ongoing Communications with NIEHS

As part of planning and coordination, the Principal Investigator provides 
leadership and guidance in fulfilling the stated objective of the program.  
To accomplish this the Principal Investigator should create within the 
Administrative Core an infrastructure that supports inter- and multi- 
disciplinary research. This infrastructure should provide an environment that 
promotes cross-discipline interactions among all of the projects and cores. 

To support the Principal Investigator in achieving these goals, NIEHS 
requires that the Principal Investigator establish an external advisory 
committee. The advisory group would evaluate: 

o the merit of the research
o the relevance and importance of the individual components to the goals of 
the program
o the integration of research across disciplines
o the appropriateness of outreach activities
o the effectiveness of translating research to appropriate audiences
o the effectiveness of training activities

Based on the evaluation, the committee would then make recommendations to the 
Principal Investigator regarding future efforts in these areas.

The external advisory committee should meet at least once annually. The 
composition of the committee should include appropriate scientific expertise 
as well as represent appropriate stakeholder interests. For example, not only 
should the academic community be represented on the committee, but also other 
stakeholders, such as industry, community or government representatives 
should be selected to serve on the committee.

The NIEHS anticipates that the administrative core will reflect 
responsibilities for fiscal and administrative management of the program. 

NIEHS considers communication with SBRP associated staff to be a high 
priority and places this responsibility within the Administrative Core. 
Therefore, as part of the Administrative Core, NIEHS requires that a plan be 
established for ensuring the effective communication and transfer of 
important research findings and other program outcomes to NIEHS. This plan 
should include identifying a point-of-contact for NIEHS who is knowledgeable 
in and informed of program activities. This plan should include a direct line 
of communication between the Administrative Core and the Research Translation 
Core such that all Research Translation Core activities can be reported to 
SBRP program managers.

Research Translation Core

Beyond the requirement discussed in the Administrative Core of communicating 
research findings to NIEHS, it is equally important that the grantees 
actively communicate important research outcomes to appropriate audiences to 
ensure the accurate and timely use of data. Accordingly, NIEHS includes, as a 
required component, the establishment of a Research Translation Core. For the 
purpose of this RFA, SBRP defines Research Translation to be "communicating 
research findings emanating from the program in the manner most appropriate 
for the intended audience." Examples of appropriate audiences are EPA 
Headquarters, EPA Regional Offices, ATSDR, state and local governments, 
health professionals, industry, etc. Under this Core, a strategy must be 
developed that describes how partnerships and other communication tools can 
be employed to ensure that the program's research is being appropriately 
applied to immediate environmental and health issues. As part of this 
strategy, the applicant should describe opportunities for receiving feedback 
from the designated audience confirming the utility and appropriateness of 
the communication tools selected.

The SBRP envisions that this Core will be the proactive communication arm of 
the program. Required components of this Core are as follows:

o Partnerships with Governmental Agencies: Of paramount importance to this 
effort is the establishment of ongoing communication with the federal, state 
and/or local agencies charged with protecting human health and the 
environment. Each program is required to propose a plan explaining how 
interactions with the appropriate regional or national governmental agencies 
will be achieved. The intent of this is to ensure that governmental offices 
have first-hand access to the valuable resources the program can provide, and 
that the investigators have knowledge of the real and immediate needs faced 
by their counterparts in the public sector.  

In the past, one valuable activity for some projects and cores has been to 
conduct research or collect samples from Superfund sites. These activities, 
of course, are always done in concert with appropriate site officials.  If 
this type of activity is part of the program, the applicant should propose a 
method for documenting and communicating these activities as part of their 
plan for partnering with government agencies.

o Technology transfer: It has always been necessary and important that the 
research generated within a program find its way into the hands of an end-
user, whether that is in the commercialization of a product or the use of 
that information/data in decision-making. Therefore, it is imperative that 
the applicant considers the ultimate use or application of the research 
emanating from its program. Each applicant must include in the Research 
Translation Core a plan for identifying opportunities for moving research 
findings into application. For some applicants, the plan may include formal 
technology transfer (i.e., application for patents), and for others, 
technology transfer may be conducted on a less formal basis (i.e., non-
patented application of research advances -– moving research from bench scale 
to demonstration). Regardless of the approach, the plan should include a 
description of how research within the program will be identified for 
technology transfer and outline the anticipated steps involved in the 

o Communicating to Broad Audiences: The applicant should consider who are the 
other stakeholders for his/her program, and how to ensure that these groups 
have timely access to research findings. Accordingly, as part of the Research 
Translation Core, the applicant must identify the mechanism to be used for 
sharing research findings and engaging important stakeholders.  Examples of 
approaches that the applicant may develop, include, but are not limited to:

- Sponsorship of workshops, short symposia, or web-based symposium. 
Applicants are encouraged to incorporate opportunities for advancing their 
program's discoveries using this mechanism. These would typically be one-day 
events that are local or regional in nature and could potentially involve not 
only academics but also other stakeholders (e.g., industry or local or 
regional health departments). 

- Development and use of advanced communication tools or methods such as web-
based systems, geographic information systems or other technologically 
innovative systems. 

- Development and use of more traditional communication tools such as the 
translation of complex research findings into print and web materials 
intended for the lay public based on communication best practices.

Research Support Cores 

Research Support Cores are principally designed as a service or resource 
component to the research projects within a program. Core facilities may 
include laboratory and clinical facilities, biostatistics and/or 
bioinformatics support, and analytical equipment and services. The NIEHS 
requires a minimum of one Research Support Core. By definition, a Research 
Support Core must function to support two or more research projects. The 
intent of a Research Support Core is to provide centralized services that 
will produce an economy of effort and/or savings in overall costs.  
Furthermore, these cores also promote interdisciplinary activities.

Community Outreach Core

Throughout the life of the SBRP, there has always been an "Outreach" 
component of the Program. While the intent of this activity has consistently 
sought to provide the Program's stakeholders with information emanating from 
SBRP in a manner and format that is useful and informative, the intended 
"audience" has evolved over time. At this point, the SBRP has targeted the 
Outreach Core specifically to Community Outreach with the intent of primarily 
focusing on health-related issues. This change is being made in order that 
the SBRP be better positioned to meet the needs of the Superfund Program's 
mandate to more actively involve the community in the decision-making 

Accordingly, NIEHS strongly recommends that programs formulate a Community 
Outreach Core that is designed to address this need. For the purpose of this 
RFA, SBRP defines community outreach to be "extending support or guidance to 
communities, community advocates or community organizations living in 
proximity to or affected by hazardous waste sites."  For example, appropriate 
community groups could include local government, tribal councils, established 
groups/organizations focused specifically on local environmental/site issues, 
or community service groups focused on educating the community about local 
issues. As an outgrowth of this activity, it is expected that interactions 
with the community will also serve to enhance the program's research agenda.

The SBRP encourages that community outreach activities be done in full 
partnership with the target community. In other words, the community should 
participate in the design and approach of the activity at the onset of the 
project. It is also appropriate that community outreach activities be done in 
conjunction with the EPA, the ATSDR, or other technical assistance programs.  
At the same time, it is important that the applicant ensure that their 
efforts do not duplicate other agencies activities.  

The Community Outreach Core should build from the strengths of the research 
program, and offer the community expertise and knowledge that draws from the 
program as well as from other resources. However, if outreach involves 
communication to lay audiences, it is suggested that individuals be included 
with expertise in fields such as technical communication, risk communication, 
health education and promotion, or health communication to ensure quality and 
to avoid unintended effects.

Community outreach activities may be either very broad or very focused.  
Examples that are appropriate for a Community Outreach Core are:

o Sponsoring short courses or workshops to improve the community's awareness 
and understanding of environmental health issues (e.g., conducting a workshop 
that provides information on exposure levels that may or may not pose serious 
health risks and why, and develop an approach for addressing the issues).

o Increasing access to relevant information and serving as a resource (e.g., 
responding to community's questions on cumulative risk or the need for 
comprehensive risk assessments, assisting them in accessing pertinent 
information or translating materials into the community's native language).

o Education on health and technical issues (e.g., sponsoring a short course 
on risk assessment, or developing health effects fact sheets).

o Establishing collaborative projects among communities, investigators and 
other colleagues to address environmental problems (e.g., partnering with 
tribes in determining exposure pathways specific and relevant to their 
traditional and cultural practices).

It is important that the Community Outreach Core define the approach it will 
use to identify a community/organizational unit with which it proposes to 
collaborate, and present a plan detailing the objectives and the methods 
(e.g. conducting small group discussion or listening sessions, producing 
informational materials, providing leadership mentoring, etc.) that will be 
used in establishing and maintaining involvement with the community. The SBRP 
also recognizes that any activity of this nature needs to be reviewed for 
lessons learned and outcomes. Accordingly, the SBRP anticipates that each 
Community Outreach Core should include in its plan how it will measure 
milestones or outcomes.

The Community Outreach Core is limited to $100,000 direct costs, and it is 
expected that the Core will complement the research strengths of the program.  
Support for appropriate staff positions, consultants, travel and supplies are 
allowed. The budget should include travel to the SBRP annual meeting with 
other Community Outreach Core Leaders.

Training Core

An area of importance to the overall performance of the Program, and to the 
future of environmental health research in general, is training. For the 
purpose of this RFA, SBRP intends that the Training Core will be used to 
support graduate and advanced training in environmental health, environmental 
sciences, ecology, and geosciences (including hydrogeology, geologic 
engineering, geophysics, geochemistry, and related fields) in the setting of 
the research program. Applicants are encouraged to propose specific plans for 
interdisciplinary training as part of their overall program.  

The Training Core should reflect the interdisciplinary nature of the overall 
research effort. Of special interest is the cross training of students and 
post-doctoral fellows in disciplines not traditionally linked in the 
university structure. Students pursuing degrees in the non-biomedical areas 
should be encouraged to place their studies in the context of environmental 
health sciences and biomedical research. Likewise, students of the biomedical 
sciences should have cross training opportunities to learn about the non-
biomedical areas of study.

In addition to providing students with unique opportunities in 
interdisciplinary research as part of their academic training, the SBRP also 
encourages the Training Cores to provide students with other skills that will 
enable these emerging investigators to be better prepared for their careers 
in science. For example, all researchers need to know how to communicate 
their work in a manner easily understood by the intended audience – whether 
the audience be the public or professionals in other areas of science. A 
case-in-point is the SBRP itself. Due to its multidisciplinary nature, 
researchers are required to effectively communicate their research beyond the 
boundaries of their individual scientific discipline. Because of this need, 
the SBRP encourages the Training Core to provide experiences for its students 
in the development of effective communication skills. Another important 
opportunity for students is the participation in the Community Outreach Core. 
The SBRP encourages the Training Core to formally support cross training of 
this nature. An opportunity such as this will provide students with valuable 
insights on the full cycle of the research that they conduct.

It is important to note that the training of pre- and post-doctoral students 
may be carried on outside the structured Training Core. In these cases, the 
budgets for these students should be part of the project or core budgets 
rather than the Training Core budget.

In keeping with the NIH efforts to train members of minority groups, and 
those with disabilities, in its ongoing training programs, applicants are 
encouraged to consider these candidates in their recruitment efforts.

Individuals in the training positions must be considered employees of the 
institution and not trainees receiving stipends as in National Research 
Service Award programs. Salaries and fringe benefits consistent with 
institutional policies may be requested. Funds may also be requested for 
tuition, where appropriate, and travel to one scientific meeting per year.  
The total costs of the Training Core are not to exceed six percent of the 
total budget.

SBRP External Guidance

The NIEHS received guidance and scientific directions in the development of 
this solicitation from numerous and diverse sources. Specifically, the below 
mentioned resources have assisted us in developing research objectives and 
identifying other components in the RFA. Full documents and reports detailing 
these interactions plus other useful information can be found at the SBRP RFA 
Web Page We encourage the 
applicant to review this site.

Guidance advocating interdisciplinary research, as presented throughout this 
document stems from the strong messages that the SBRP has received from the 
scientific community and colleagues from other federal and state agencies. In 
February 2003, the NIEHS convened an external workgroup to provide the SBRP 
with guidance on research direction and approaches. The group strongly 
endorsed the critical role interdisciplinary research can play in 
accomplishing the goals set out by the SBRP. They also advocated the use of 
emerging tools and technologies, as well as promoting a systems approach to 
addressing complex issues that hazardous waste sites present.

To ensure relevance and need, SBRP actively engaged with its colleagues in 
other governmental organizations prior to the formulation of the RFA. 
Discussions with other agencies, including the EPA and ATSDR, were 
particularly important in helping identify research gaps that, when filled, 
could assist these agencies' abilities to protect public health. Reports from 
some of the more recent meetings with other agencies identify not only 
research needs but also important suggestions for maintaining strong 
communication with their offices. Reports can be viewed on
NIEHS has an established mechanism of surveying the scientific community for 
identifying cutting edge science and critical gaps in the various disciplines 
through its sponsorship of workshops and conferences. The SBRP selects to 
support conferences in areas that are of high program interest that will 
identify emerging issues in areas of programmatic interest. Through the 
support of conferences, the NIEHS promotes the growth of a field and fosters 
interdisciplinary opportunities. Typically, meeting reports are published 
with specific emphasis highlighting emerging areas of scientific needs. The 
SBRP drew from these meetings important insights on potential future 
directions for the Program. For a complete listing of SBRP conferences and 
workshops and resultant reports and publications refer to


This RFA will use the National Institutes of Health (NIH) multi-project (P42) 
award mechanism. Beginning with the current solicitation, an RFA will be 
issued on an annual basis. Applications that are not funded in the 
competition described in this RFA may be resubmitted as amended applications 
in subsequent solicitations for this Program. As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project. The anticipated award date is April 1, 2005.  

Grants funded under this Program must be multi-project, interdisciplinary 
efforts bringing together investigators from different scientific disciplines 
to direct discrete Research Projects, each of which is to be related to the 
goals of the SBRP and to a central theme developed for the applicant's 

In order to be considered for funding, each applicant must successfully meet 
the following requirements:

Requires a minimum of:

o Three approved biomedical Research Projects (e.g., mechanistic-based 
studies, epidemiology, human risk assessment, exposure assessment, genetic 
susceptibility, etc.) and,
o One approved non-biomedical Research Project (e.g., ecology, ecological 
risk assessment, fate and transport, hydrogeology, engineering, remediation, 
phytoremediation, etc.)

Historically research projects have been categorized as biomedical and non-
biomedical to ensure the multidisciplinary focus for environmental health 
research as it relates to Superfund issues.  However, the scientific 
community recognizes that cross-disciplinary research is necessary to advance 
the field. Accordingly, projects that integrate biomedical and non-biomedical 
aims within a single research project should be considered.   

Requires an approved Administrative Core to include:

o an External Advisory Committee 

Requires a minimum of one approved Research Support Core:

o A Research Support Core must provide support to two or more Research

Requires an approved Research Translation Core to include:

o A plan for Partnerships with Government Agencies 
o A plan for Technology Transfer 
o A plan for Communicating to Broad Audiences 

It is critical that the applicant recognize that the SBRP is more than just a 
basic research program and the applicant should make investments in other 
crucial areas of the Program. Therefore, in addition to the required 
elements, the SBRP strongly encourages the inclusion of:

o An Outreach Core 
o A Training Core 

The following restrictions or caps are applicable to each program:

o The total number of Research Projects and Research Support Cores cannot 
exceed 12. The Administrative, Research Translation, Outreach or Training 
Cores do not count towards this total.

o The applicant is required to specify which projects are to be considered 
biomedical research and which are to be considered non-biomedical research.

This RFA uses just-in-time concepts and the non-modular budgeting format.  
Applicants must use the forms for regular research grants, follow the 
specific instructions in the PHS 398 application kit, and provide a complete 
detailed budget (Forms Pages 4 & 5) with narrative justifications. This 
program does not require cost sharing as defined in the current NIH Grants 
Policy Statement at

The NIEHS intends to commit approximately $27 million in FY 2005 to fund 
eight to ten new and/or competitive continuation grants in response to this 
RFA. Applicants may request a project period of up to five years.  The 
maximum budget that can be requested is $2.1 million in direct costs for the 
first year. The budgets for each subsequent year may not exceed an escalation 
of three percent on recurring direct costs. Facilities and Administrative 
(F&A) costs incurred by including third party consortia or subcontracts in 
the application will not contribute to the $2.1 million cap in direct costs.  
Applications that exceed the $2.1 million direct cost cap (excluding third 
party F&A) will be returned as non-responsive to the RFA. 

As discussed in the "Description of the SBRP" section of this RFA, beginning 
with the current solicitation, the Program is transitioning from a 
competition held once every five years to an annual competition. In order to 
accomplish this transition in a timely and efficient manner, applications 
awarded in Fiscal Years 2005 and 2006 may be funded for three, four or five 
years. Decisions on the length of funding will be based on technical merit, 
programmatic balance and availability of funds.  

Although the financial plans of the NIEHS provide support for this program, 
the funds that are appropriated for the SBRP are determined each year 
according to the Federal budget process. Because the funding level of this 
Program may vary from year to year, awards pursuant to this RFA are 
contingent upon the availability of funds and the receipt of a sufficient 
number of meritorious applications. The actual award levels for approved and 
funded applications will be based on Program balance and the availability of 
funds, in addition to the scientific merit considerations of the review 

You may submit an application if your institution has the following 
o Accredited institution of higher education
o Foreign institutions are not eligible to apply 

Section 311(a)(3) of SARA limits recipients of awards to "accredited 
institutions of higher education," which are defined in the Higher Education 
Act, 20 USC (annotated) 3381. However, grantees are permitted under the law, 
and encouraged by NIEHS, to subcontract as appropriate with organizations, 
domestic or foreign, public or private (such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government) as necessary to conduct portions of the 
research. Examples of other organizations may include generators of hazardous 
wastes; persons involved in the detection, assessment, evaluation, and 
treatment of hazardous substances; owners and operators of facilities at 
which hazardous substances are located; State and local governments and 
community organizations.

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


Annual Meetings: It is the intent of the NIEHS to hold annual grantee 
meetings under this Program. Funds for travel by appropriate staff (i.e., 
Principal Investigator, Business Manager, and three students) to attend a 
three-day meeting should be included in the Administrative Core's budget for 
each year. It is also anticipated that the Outreach Core and Research 
Translation Core Leaders will convene at the annual meeting, and expenses for 
this travel should be included in their individual budgets. The location of 
the meeting site will rotate among the different grantees. 
Quality Assurance Statement:  Quality Assurance Statements will be necessary 
ONLY for Research Support Cores that provide analytical, quantitative 
services to the applicant's program. 

EPA regulations as stated in 40CFR30.54 require the inclusion of a Quality 
Assurance Narrative Statement (QANS, OMB # 2080-0033, approved 8/14/97) for 
any project application involving data collection or processing, 
environmental measurements, and/or modeling. The QANS provides information on 
how quality processes or products will be assured. While applications to 
NIEHS/NIH cannot be considered incomplete without this statement, EPA cannot 
fund any application without a reviewed QANS; therefore it is requested that 
the QANS be included with all applications. For awards that involve 
environmentally related measurements or data generation, a quality system 
that complies with the requirements of ANSI/ASQC E4, "Specifications and 
Guidelines for Quality Systems for Environmental Data Collection and 
Environmental Technology Programs," must be in place. The Quality Assurance 
Statement should not exceed two pages. This Statement should, for each item 
listed below, present the required information, reference the specific page 
and paragraph number of the project description containing the information, 
or provide a justification as to why the item does not apply to the proposed 

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

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

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

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

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

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

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


We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants. Because of the complexity of the 
SBRP, applicants are strongly encouraged to contact NIEHS staff early in the 
grant preparation process. 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:

Claudia Thompson, Ph.D.
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233 MD EC-27
Research Triangle Park, NC 27709
Telephone:  919-541-4638
FAX:  919-541-4937

Beth Anderson
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233 MD EC-27
Research Triangle Park, NC 27709
Telephone:  919-541-4481
FAX:  919-541-4937

William Suk, Ph.D., M.P.H.
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233 MC EC-27
Research Triangle Park, NC 27709
Telephone:  919-541-0797
FAX:  919-541-4937

o Direct your questions about peer review issues to:

Sally Eckert-Tilotta, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-30
Research Triangle Park, North Carolina 27709
Telephone: 919-541-1446
Fax: 919-541-2503

Janice Allen, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-30
Research Triangle Park, North Carolina 27709
Telephone: 919-541-7556
Fax: 919-541-2503

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

Susan Ricci
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-30
Research Triangle Park, North Carolina 27709
Telephone: 919-316-4666
Fax: 919-541-2860

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 NIEHS staff to estimate the potential review workload and 
plan the review.
The letter of intent is to be sent by February 13, 2004.  The letter of 
intent should be sent to:

Sally Eckert-Tilotta, Ph.D.
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: 919-541-1446
Fax: 919-541-2503


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at  The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 document is available at in an interactive 
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, 

As the PHS 398 is used primarily for the traditional research project grant 
applications, several sections of the PHS 398 must be modified and expanded 
to provide the additional information needed for the Superfund Basic Research 
and Training Program applications. Detailed guidelines to supplement the PHS 
instructions are provided in the "Application Guidelines for the Superfund 
Basic Research and Training Program" and can be found on:


Prospective applicants are invited to attend an informational meeting on 
applying for an SBRP grant. For the convenience of the applicant, NIEHS staff 
will hold an "Applicant Information Meeting" (AIM) at the NIEHS in Research 
Triangle Park, North Carolina, on October 29, 2003.  NIEHS staff will explain 
the purpose of the Program, provide instructions about the application 
process, and answer questions. While the meeting will not be video-cast live, 
it will be made available on the web for subsequent viewing. Further 
information and registration forms can be found at the following Web site: Archives of this event and 
additional information for future web-based seminars will also be available 
at this link.    
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:
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and two signed, photocopies 
(exclude appendix materials), 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 signed copies of the application 
and five copies of collated (clearly identify collated appendix materials 
associated with each project and core; do not staple or bind) appendix 
material MUST be sent to the NIEHS Scientific Review Administrator:

Sally Eckert-Tilotta, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-30
79 T. W. Alexander Drive, 3rd Floor, Room 3167 (Courier/Express)
Research Triangle Park, North Carolina 27709
Telephone: 919-541-1446
Fax: 919-541-2503
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 

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.


Upon receipt, applications will be reviewed for completeness by the CSR.  
NIEHS staff will do an administrative review for completeness and 
responsiveness to the RFA. Incomplete and/or non-responsive applications will 
not be reviewed. The specific points of consideration to determine 
completeness and responsiveness are: (1) the appropriateness of the science 
proposed in regard to the mission of the NIEHS and the SBRP's mandates; (2) 
the general completeness of the application including responsiveness to 
programmatic requirements (as listed under "Mechanism of Support"); (3) the 
organizational adequacy for review (this includes both scientific and 
budgetary considerations); and (4) the adherence to the $2.1 direct cost 
ceiling (see "Funds Available").  

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
[Special Emphasis Panel, (SEP)] convened by the NIEHS in accordance with the 
review criteria stated below. The SEP will include scientific and technical 
experts with the necessary proficiency to adequately review the biomedical 
and non-biomedical science as well as all other components of the 
application. Since these applications are complex and formal site visits are 
not planned, it is essential that all applications be thoroughly prepared and 
that they be well organized in accordance with the guidelines.

As part of the initial merit review, all applications will:

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top two/thirds of the applications 
under review, will be discussed and assigned a priority score.
o Receive a written critique.
o Receive a second level review by the NIEHS National Advisory Environmental 
Health Sciences (NAEHS)Council.

As part of the initial scientific review for competitive applications, the 
applicant will have the opportunity to address questions/concerns that the 
panel may have. During the initial review meeting, the applicant will be 
asked to be available via telephone to address the SEP, if necessary. Each 
applicant will receive a call even if no additional information is required. 

It is important to note that SEP members will examine proposed budgets 
closely.  The SEP may recommend adjustments, as judged appropriate, in the 
requested budgets and periods of support for the components of SBRP 
applications which are deemed to have significant and substantial merit. 

Submission of Additional Information by Applicants

There is a period of several months between the time of submission of the 
application and the initial review. In the event of substantial new findings 
during this interval, the applicant is encouraged to contact the SRA to seek 
permission to submit supplementary materials. These materials will generally 
not be accepted within 30 days prior to the initial scientific review. The 
SRA will make the final determination as to what additional information will 
be provided to the reviewers. Please note, this is information that the 
applicant wishes to include and not information being requested by the SEP 
members as described above.

NAEHS Council Review

The NAEHS Council makes the final review and recommendation on all scored 
applications. The Council has two responsibilities relating to grant 
applications under review: (1) it evaluates the adequacy and appropriateness 
of the initial review process, and (2) it considers the significance of the 
application to the overall program goals of the NIEHS. Upon consideration of 
these issues the Council makes appropriate recommendations to the Director, 
NIEHS. The Council does not function as a second scientific review body. 

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
Within this context, the goal of the SBRP is to improve public health by 
supporting integrative interdisciplinary research that includes the ability 
to identify, assess, and evaluate the potential health effects of exposure to 
hazardous waste and to develop innovative chemical, physical and biological 
technologies for reducing potential exposure to hazardous substances. In the 
written comments, reviewers will be asked to evaluate the application, as 
described below, in order to judge the likelihood that the integrated 
research and related efforts will have a substantial impact on the pursuit of 
SBRP goals.

The scientific review group will address and consider each of the following 
criteria in assigning the application's overall score, weighting them as 
appropriate for each application. The application does not need to be strong 
in all categories to be judged likely to have major scientific impact and 
thus deserve a high priority score. For example, an investigator may propose 
to carry out important work that by its nature is not innovative but is 
essential to move a field forward.

(A) Review Factors for the Overall SBRP Application

The scientific review panel will evaluate the inter-relationship and 
contributions of the research projects and cores to an overall conceptual 
theme and goals of the program as well as the scientific merit of the program 
as a whole. This includes the significance and importance of the research 
program to further the knowledge of environmental health sciences and the 
understanding of the physical, chemical and biological properties of 
hazardous substances in the environment and the translation and delivery of 
the research findings to appropriate audiences. There must be evidence of the 
potential for meaningful interdisciplinary collaboration between all of the 
components of the program. Components that are not recommended for further 
consideration are not included in the overall evaluation; however, such 
projects will reflect on the leadership capabilities of the Principal 

For a SBRP application to receive a priority score, it must consist of at 
least three biomedical projects, one non-biomedical project, a Research 
Translation Core, a minimum of one Research Support Core (each found to have 
significant and substantial merit) for the duration of the project period and 
an acceptable Administrative Core. Each Research Support Core must provide 
essential functions or services for at least two Research Projects. 

(B) Review Factors for Renewal Applications

In addition, for competing renewal applications the following will be 

o Progress and achievements specific to this program since the previous 
competitive review and the documentation through publications, conferences, 
etc., that demonstrates that collaboration between or among projects has 

o Previous performance and estimated use of the core(s).

o Justification for adding new projects or cores or for deleting components 
previously supported.

o Prior commitment to transferring research findings to appropriate audiences 
such as EPA, EPA Regions, ATSDR, State and local professionals or other 
professionals working in the field of hazardous waste management.

(C) Review Factors for the Research Projects

The review of the individual Research Projects is similar to the review of 
investigator-initiated individual project grant applications (R01).  
Accordingly, these projects must have substantial scientific merit.  
Reviewers will evaluate the individual projects against five review criteria.  
The four technical review criteria (Significance, Approach, Innovation and 
Environment) are intended to encourage reviewers to focus on the global 
impacts of each project, rather than concentrating on the experimental 
details and their critiques. The review criteria are as follows: 

SIGNIFICANCE: Does this study address an important problem? If the aims of 
the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

APPROACH: Are the conceptual 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 tactics?

INNOVATION: Does the project employ novel concepts, approaches or methods?  
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?

INVESTIGATOR: Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?

ENVIRONMENT: Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support? 

For competing renewals, reviewers will evaluate whether previous specific 
aims, as funded, have been accomplished and that the new research goals are 
logical extensions of ongoing work.

Additionally, reviewers will evaluate each project for its contribution to 
the overall goals of the SBRP application:

o Scientific merit of each individual project in the context of the proposed 
programmatic theme, (i.e., assessment of the importance of the ideas or aims, 
the rationale and originality of the approach, the feasibility of the methods 
and the value of the result).

o Specific scientific objectives of each project that will benefit 
significantly from, or depend upon, collaborative interactions with other 
projects in the program (i.e., objectives that can be uniquely accomplished, 
specific contributions to the accomplishments of objectives in other 
projects, objectives that can be accomplished with greater effectiveness 
and/or economy of effort, etc.).  

In addition to the review criteria described above for research projects, the 
following will be considered by the SEP in evaluating the cores, the 
multidisciplinary and interdisciplinary nature of the program and the 
principal investigator (sections D-J).

(D) Review Factors for the Research Support Cores

o Overall use of each core.  Does each Research Support Core provide 
essential facilities or service for two or more of the Research Projects 
judged to have substantial scientific merit?  Is the projected use sufficient 
to warrant establishment of the core?

o Are the core facilities contributing to the overall research activities of 
the program? 

o Are the requests for equipment, supplies and other items to support the 
activity of the core appropriate and justified?

o Is the of use of the core, in the context of the quality, breadth and 
utility of services provided, cost effective and efficient? 

o Is there a plan to prioritize core usage?

o Is the Quality Control and Quality Assurance plan for cores that are 
providing quantitative analyses adequate? 

o Are the personnel involved in the core qualified and do they have the 
appropriate experience and level of commitment?

o For competing renewals, have the previous specific aims, as funded, been 

(E) Review Factors for the Administrative Core

o Lines of authority and the administrative structure to manage a multi-
project program. Does the program's internal plan promote coordination of 
interdisciplinary research, stimulate collaborations among constituent 
Research Projects and Cores, and evaluate research productivity? Is there a 
decision-making process for the management of funds and resources?  Is there 
an ability to provide administrative support to the project and core leaders? 

o External advisory committee.  Is there an appropriate plan to establish and 
use an external advisory committee? Do the members of the committee have the 
expertise required to evaluate all projects and cores and appropriately 
represent the applicant's stakeholders?

o Are the senior leaders of the administrative core qualified and have they 
demonstrated effective and responsible leadership in the past?  Is the 
percent effort requested adequate? 

o Are the qualifications, duties and percent efforts of administrative staff 
appropriate to contribute to the needs and conduct of the program's research 

o Is there a plan to coordinate and exchange information with SBRP staff?

o Are the resources committed to the Administrative Core adequate?

(F) Review Factors for the Research Translation Core

o Are the proposed personnel qualified to conduct the activities described 
for the Core?

o Is the proposed plan to partner with governmental agencies adequate?

o Is the proposed plan to identify technology transfer opportunities 

o Communication with broad audiences adequate.  Is there adequate commitment 
and support for the approach being developed?  Are the communication tools 
selected appropriate for the intended audience?

o Are the resources committed to the Research Translation Core adequate for 
the proposed activities?

(G) Review Factors for the Community Outreach Core

o Is the proposed approach appropriate, adequate and feasible? 

o Is there sensitivity to socioeconomic and cultural factors and have these 
been adequately addresses? 

o Are the plans adequate for coordination and collaboration with appropriate 
community groups, and state, local and federal agencies?

o Do the core members have appropriate qualifications and experience to 
fulfill the goals of the outreach core? 

(H) Review Factors for the Training Core

o Objectives, design, and direction of the research-training program. Are the 
approaches and methods used adequate to develop training curriculum and 
courses that provide opportunities to interface with different scientific 
disciplines?  Does the training program reflect the interdisciplinary nature 
of the program? 

o Are the plans for the recruitment and selection of individuals 
participating in the Training Core appropriate?

o Adequacy of the training environment.  Is there institutional commitment? 
Are the quality of the facilities and the availability of courses appropriate 
to the SBRP?  Is there an availability of research support for post-doctoral 

o For competing renewals, have the previous specific aims, as funded, been 

(I) Review Factors for the Multidisciplinary and Interdisciplinary Nature of 
the Program

o Interdisciplinary nature of the proposed research activities.  Is there 
integration of the projects around a central theme?  Are there plans to 
effectively pursue interdisciplinary research objectives? 

o Synergy of the program.  Is the whole greater than the sum of the parts?  
Is the size of the program sufficient to afford effective interaction focused 
on a specific central theme, but diverse in scientific disciplines in order 
to achieve meaningful contributions to protecting human health and the 

o Is there evidence of integration and interaction of the non-health related 
research with the health-based research as it contributes to the central 
theme of the program?

(J) Review Factors for the Principal Investigator

o Does the Principal Investigator have the necessary leadership and 
scientific experience to effectively direct a large complex multidisciplinary 

o Does the Principal Investigator demonstrate an appropriate level of 
commitment and have the ability to develop a well-defined central research 

o Does the Principal Investigator demonstrate the appropriate ability and 
experience to coordinate the interactions of the Research Projects with 
effective utilization of cores to achieve programmatic goals?

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:

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).
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 in the sections on Federal Citations, 

be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct 
costs in any year of the proposed research must include a data sharing plan 
in their application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the reviewers. 
However, reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. (for NIH instructions 
and policy see

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


Letter of Intent Receipt Date: February 13, 2004
Application Receipt Date: April 21, 2004
Peer Review Date: October 2004
Council Review: February 2005
Earliest Anticipated Start Date: April 1, 2005


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.

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998:  

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 or 
more in direct costs in any single year are expected to include a plan for 
data sharing or state why this is not possible. Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is 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 clinical research should read the "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 
a complete copy of the updated Guidelines are available at
The amended policy incorporates: the use of an 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 require 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 

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

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at and at Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see   
It is the responsibility of the applicant to provide, in the description and 
elsewhere in the application as appropriate, the official NIH identifier(s) 
for the hESC line(s)to be used in the proposed research. Applications that do 
not provide this information will be returned without review. 

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

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.

Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
( provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes 
involving the review, funding, and progress monitoring of grants, cooperative 
agreements, and research contracts can be found at

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 
RFA is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review. Awards are made under authority of the Superfund 
Amendments and Reauthorization Act of 1986, Title 1, Section III, and Title 
II, Section 209 (Public Law 99-499); and are made under the authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 
and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 
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
The PHS strongly encourages 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 mission to protect and advance the physical and mental health of the 
American people.

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