CENTERS FOR OCEANS AND HUMAN HEALTH

RELEASE DATE:  November 21, 2002 

RFA:  ES-03-003

National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov)
National Science Foundation (NSF)
 (http://www.nsf.gov)

LETTER OF INTENT RECEIPT DATE: February 17, 2003

APPLICATION RECEIPT DATE: March 17, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS RFA

The National Institute of Environmental Health Sciences (NIEHS) and the 
National Science Foundation (NSF) (hereafter "the Government" or "the 
Participating Agencies") invite applications for establishment of research 
programs to elucidate underlying mechanisms that govern relationships between 
marine processes and public health.  The purpose of Centers for Oceans and 
Human Health (COHH) is to provide linkages between members of the ocean 
sciences and biomedical communities in order to support interdisciplinary 
research in areas where improved understanding of marine processes and systems 
has potential to reduce public health risks and enhance existing biomedical 
capabilities.  COHH are expected to create an environment conducive to 
interdisciplinary and reciprocally beneficial collaborations among biomedical 
scientists (e.g., epidemiologists, pharmacologists, toxicologists, 
microbiologists, cell and molecular biologists) and ocean scientists (e.g., 
biological and physical oceanographers, geochemists, and ecologists) with the 
common goal of improving our knowledge of the impacts of the ocean on human 
health.

This RFA draws on the recommendations contained in the strategic plans of the 
Participating Agencies (NIEHS Strategic Plan 2000, 
http://www.niehs.nih.gov/external/plan2000/home.htm; NSF Geosciences Beyond 
2000, http://www.geo.nsf.gov/adgeo/geo2000.htm; Environmental Science and 
Engineering for the 21st Century:  The Role of the National Science 
Foundation, http://www.nsf.gov/nsb/tfe/nsb99133), those highlighted by the 
Ocean Studies Board of the National Research Council (AFrom Monsoons to 
Microbes: Understanding the Ocean=s Role in Human Health,@ National Academy 
Press, 1999), and those discussed at a Government-sponsored Roundtable on 
Oceans and Human Health in Research Triangle Park, NC, December, 2001 (see 
report at http://www.niehs.nih.gov/translat/news.htm

ELIGIBLE INSTITUTIONS

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

o  For-profit or non-profit organizations 
o  Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o  Units of state and local governments
o  Eligible agencies of the federal government  
o  Domestic
o  Faith-based or community-based organizations

Foreign organizations are not eligible to apply for this program, although an 
international partnership with a lead domestic institution is possible.  
Applications may represent a single institution, or may involve several 
institutions or organizations.  Minority individuals, women, and persons with 
disabilities are encouraged to apply as principal investigators. 
 
Applications are encouraged from institutions holding other Center grants in 
biomedical or ocean sciences from the Participating Agencies as well as other 
public and private funders.  The skills and capabilities of these Centers may 
synergistically strengthen research on oceans and human health.  It is 
expected that consortia of institutions that might include medical schools, 
environmental health science centers, ocean science centers, and schools of 
public health will best support interdisciplinary COHHs.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with 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 Government programs.   

MECHANISM OF SUPPORT

The participating agencies will jointly administer the program throughout the 
duration of awards.  Each award will be supported by NSF or NIEHS 
individually, or through joint awards from both agencies, per agreements among 
these organizations.  Principal Investigators may be requested to modify their 
budgets and work plans to comply with special requirements of the agency 
(agencies) supporting their award. Grant awards by the NIEHS will use the P50 
Specialized Centers Grant.  Applicants are encouraged to discuss this 
mechanism with the Program Representatives named below.  As an applicant you 
will be solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  The anticipated award date is 
September 30, 2003.

This RFA uses the non-modular budgeting format.  Follow the instructions for 
non-modular research grant applications.

FUNDS AVAILABLE

The Government intends to commit approximately $6,000,000 total costs annually 
to fund four new grants of up to five years in duration in response to this 
RFA.  An applicant may request a budget for direct costs of up to $1,000,000 
per year.  Should an applicant plan to include subcontracts to other 
institutions or organizations, only the direct costs associated with the 
subcontracts will be used to tally the direct costs that apply toward this 
cap.  Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and duration of 
each award will also vary.  Although the financial plans of the Participating 
Agencies provide support for this program, awards pursuant to this RFA are 
contingent upon the availability of funds and the receipt of a sufficient 
number of meritorious applications. 

RESEARCH OBJECTIVES

Background of Agency Partnership    

In view of the marked relationship between human populations and the marine 
environment, it is remarkable that concerted scientific interest in the 
interplay between marine processes and public health has emerged only 
recently.  This slow development may be due, at least in part, to the 
difficulty attendant with bringing together appropriate talent from relevant 
scientific fields, e.g., public health, preventive medicine, infectious 
disease, environmental epidemiology, ocean chemistry and biology, and 
geophysics.  Hence, development of strategies for creating interdisciplinary 
teams of scientists is essential for enhancing our understanding of the causal 
linkages between marine processes and public health and for eventual 
production of predictive models and successful interventions.  

NIEHS and NSF support complementary sets of expertise within their respective 
extramural research communities that can be brought to bear to address oceans 
and human health more thoroughly and completely than any single agency or 
single set of expertise could do on its own.  Hence, the Participating 
Agencies have joined forces to support this collaborative initiative and to 
unite and harmonize their corresponding strengths in biomedical and ocean 
sciences.  

The mission of the NIEHS is to reduce the burden of human illness and 
dysfunction due to environmental exposures.  Environmental health is broadly 
defined as encompassing the study of physical, chemical, biological, and 
social exposures on human health and quality of life (Healthy People, 2010).  
NIEHS carries out its mission through a three-pronged approach: basic 
biomedical research to improve our understanding of the causes and mechanisms 
of environmentally related disease; intervention research to enhance 
development and conduct of prevention strategies; and a variety of 
communication efforts to disseminate findings to the American public, 
including community outreach, education, training, and technology transfer.  
The NIEHS presently supports a number of research efforts that may be related 
to the general study of marine processes and human health, including effects 
of toxins from harmful algal blooms (HABs), contaminated seafood consumption, 
and a set of Marine and Freshwater Biomedical Science Centers, which are 
primarily focused on developing aquatic models for use in toxicology.  
However, the Institute has not previously supported studies addressing how 
physical and chemical properties inherent to the world=s oceans directly 
impact human health.  

NSF is an independent Federal agency whose mission is "to promote the progress 
of science; [and] to advance the national health, prosperity, and welfare by 
supporting research and education in all fields of science and engineering" 
(National Science Foundation Act of 1950, as amended by 42 USC 1861-75).  NSF 
is responsible for the overall health of science and engineering across all 
disciplines. In contrast, other Federal agencies support research focused on 
specific missions such as health or defense. The Foundation also is committed 
to ensuring the nation's supply of scientists, engineers, and science and 
engineering educators.   NSF funds research and education in most fields of 
science and engineering through grants and cooperative agreements to more than 
2,000 colleges, universities, K-12 school systems, businesses, informal 
science organizations and other research organizations throughout the United 
States.  The Foundation accounts for about one-fourth of Federal support to 
academic institutions for basic research.   The agency operates no 
laboratories itself but does support National Research Centers, user 
facilities, certain oceanographic vessels and Antarctic research stations. The 
Foundation also supports cooperative research between universities and 
industry, US participation in international scientific and engineering 
efforts, and educational activities at every academic level.

The field of oceans and human health currently represents a gap between the 
two Participating Agencies= missions.  As such, it also represents a logical 
opportunity for partnership.  Together, NSF and NIEHS plan to bridge this gap 
and promote state-of-the-art, interdisciplinary research that unites the 
oceanographic and medical communities, allows for cross-fertilization of ideas 
and technologies, and provides more comprehensive insight of the potential 
risks and benefits to human health generated by the oceans.   
     
Background of Scientific Opportunities

Oceans have become conduits for a number of environmental threats to human 
health.  At the same time, oceans harbor diverse organisms that show great 
promise for providing new drugs to combat cancer and fight infectious 
diseases.  To guard against such health threats and to take advantage of the 
medicinal benefits that oceans might provide, the impacts of the oceans on 
human health must be more fully explored and new research efforts directed to 
this area.

Disease-causing organisms harmful to human health can be spread by several 
different marine processes.  Coastal and estuarine circulation patterns 
influence the frequency and geographic pattern of HABs.  Nutrient loading from 
heavy runoff also poses problems of anoxia and contributes to proliferation of 
algae.  Circulation of waters through estuaries and coastal areas plays a role 
in determining where and when the risks of contamination by human pathogens 
are highest.  Pathogens from human or animal waste contaminate coastal and 
estuarine areas through freshwater runoff from sewers, rivers, and streams.  
Viruses and bacteria of fecal origin become concentrated in filter-feeding 
shellfish such as oysters and clams.  Marine pathogenic bacteria such as 
Vibrio cholera and harmful algal species can invade new areas through 
transport in the ballast water of ships.  Harmful algal species can also be 
transported great distances by major ocean currents such as the Gulf Stream.  
International trade also transmits algal toxins and pathogens through commerce 
in seafood.  

In addition to recognizing health problems associated with the ocean, the 
Participating Agencies equally recognize the contributions of marine 
biodiversity to biomedicine.  Plants, animals, and microbes have provided 
either the source or the concept for more than half of the pharmaceuticals 
currently on the market.  Despite continued and more sophisticated searches 
for new bioactive agents, there has been a decreasing return in molecular 
diversity and, correspondingly, in development of new drug compounds.  
Simultaneously, many bacteria causing life-threatening diseases have become 
resistant to existing antibiotics, making the need for new drug discovery more 
urgent.  Due to the diversity of life within the world=s oceans, marine 
organisms offer a promising source of novel compounds with therapeutic 
potential.

Based upon these considerations, the Government has identified the following 
special areas of emphasis for this initiative:

o  Harmful algal blooms (HABs)
o  Water- and vector-borne diseases
o  Marine-derived pharmaceuticals and probes

A.  Harmful algal blooms (HABs)

The environmental conditions that foster large blooms of microscopic algae are 
not well understood and seem to vary from species to species.  Red tides and 
other toxic algae have suddenly appeared in previously unaffected coastal 
areas.  For most harmful algal blooms (HABs), the underlying causes (physical, 
chemical, biological) for bloom development are not understood.  Thus, we are 
not able to predict the potential impact of HABs on human health.  For many 
HABs, potential pathways of toxins to humans are not well known, and the 
effects of low-level, chronic exposure have not been examined.

Worldwide, HABs cause a variety of acute, sub-acute, and chronic diseases in 
humans, as well as in other mammals, fish, and birds.  Health effects in 
humans range from acute neurotoxic disorders (such as paralytic shellfish 
poisoning, neurotoxic shellfish poisoning, and ciguatera finfish poisoning) to 
chronic and persistent diseases (such as amnesic shellfish poisoning and 
chronic liver disease caused by the cyanobacterial toxins, the microcystins). 
 Disease caused by exposure to the environmental chemicals produced by HAB 
organisms may be initiated by consumption of contaminated seafood or 
inhalation of toxins entrapped in sea spray.  

The ecology of each HAB is different.  Mechanisms leading to initiation, 
maintenance, and termination of a bloom are not completely understood for any 
species.  Over the last 30 years, both the range and frequency of HAB events 
have increased along US coastlines.  The reasons for this expansion are 
unknown.  The detailed mechanism of toxicity is known for only one of the 
HABs, saxitoxin.  Additional information on HAB ecology and toxicity is 
essential for development of therapeutic strategies.  
  
B.  Water- and vector-borne diseases

Humans may be exposed to marine water-borne disease via eating fish, 
especially shellfish, and recreational contact, such as swimming or surfing.  
There is little question that both routes are the cause of illness in the US 
and globally.  Shellfish are of particular concern because they are filter-
feeders and efficiently remove extremely small particles from seawater.  Some 
even feed directly on bacteria, but most target slightly larger algae and 
suspended detritus that may contain numerous attached bacteria and viruses.  
Also, many shellfish are eaten whole, including gills and stomach, and 
sometimes eaten raw. These both increase the chance of disease transmission.  
In recreational contact, illnesses can arise from skin or wound infections, 
ear, sinus, and respiratory infections, or GI and systemic infections from 
swallowing seawater. 

The principal agents of diseases that derive from seawater are bacteria, 
viruses, and protists.  Bacteria include native marine organisms (e.g., Vibrio 
vulnificus, V. parahemolyticus), but mostly those originating from humans and 
terrestrial animals.  Because viruses tend to have a limited host range, human 
pathogenic viruses in seawater most probably come from human sources 
(primarily via fecal transmission).  Protists can include native forms, such 
as toxin-producing dinoflagellates and possibly others such as Cryptosporidium 
and Giardia.

Water-borne illnesses continue to be a major killer of children throughout the 
world.  Disease incidence is increasing worldwide, promoted by both natural 
phenomena such as El Nino and human activities, including sewage disposal.  
Human- and animal-derived pathogens in seawater primarily enter the sea from 
sewage and runoff, including agricultural runoff.  Relatively little is known 
about the fates of most pathogens in marine environments.  A more detailed 
understanding of the fates of particular pathogens would necessitate specific 
studies of target pathogens, or surrogates, in selected environments of 
interest.  One relevant question is how pathogens may become attached to 
particles and sink to the sea floor, possibly to be re-suspended later.  
Sediments may protect the pathogens and serve as a long-term reservoir.  
Particle-pathogen interactions are also particularly relevant to understanding 
how pathogens may be taken up by shellfish or swimmers, and how they are 
transported.

Survival and persistence of various pathogens is strongly influenced by 
environmental conditions, and global change has the potential to alter 
significantly the existing patterns.  For example, pathogens now largely 
limited to tropical areas are likely to move pole-ward under a general warming 
scenario.  Therefore, the current pathogen types found at coastal US cities 
may change in the near future, and organisms such as pathogenic Vibrio 
cholerae may become a problem.  It is also important to realize that 
microorganisms undergo gene transfer, including genes coding for virulence 
factors and antibiotic resistance.  Therefore, relatively benign forms may 
become pathogenic and/or resistant to antibiotics, and pathogenic forms may 
become more prevalent.  As we experience increased human population pressure 
in coastal areas and changes in environmental conditions, this may lead to an 
increased importance of marine-borne pathogens.

C.  Marine-derived pharmaceuticals and probes

Nature has traditionally been the source of new pharmaceuticals.  Over 50% of 
drugs on the market today are either extracted from natural sources or 
produced by synthesis using natural products as templates or starting 
materials.  Despite new approaches to drug discovery, it seems likely that 
natural products, which have evolved over millions of years of selective 
pressures, provide one of the most important components of this process.  

The marine environment constitutes the greatest source of chemical diversity 
on the planet.  Representatives of every phylum are found in the sea; twelve 
phyla are exclusively marine.  More than 200,000 species of invertebrates and 
algae in the ocean have been described.  However, it is estimated that this 
number is only a small percentage of the total number of species yet to be 
discovered.  Based upon such diversity, the ocean represents a virtually 
untapped resource for discovery of novel chemicals with pharmaceutical 
potential.

An important application of bioactive compounds derived from the marine 
environment is their use as molecular probes, i.e., as non-drug substances 
that can be used to probe important biochemical processes. Very often, marine-
derived compounds possess unique biological properties that render them of use 
in basic biology.  For example, discovery of the potent marine toxin 
tetrodotoxin led to a much more refined understanding of the receptors for 
human pain.  Similarly, the red tide toxin okadaic acid and the sponge 
metabolite illimaquinone are now in use to probe basic cellular processes.  In 
addition, marine natural products have provided visual markers for proteins 
specified by antibodies, for cellular events mediated by calcium, and for 
elucidating mechanisms of tissue-specific gene expression.        

Objectives and Scope    

The purpose of this RFA is to support interdisciplinary research leading to 
improved understanding of the connections between oceans and human health.  
COHH will be multidisciplinary research programs in the diverse areas of 
oceanography, climatology, ecology, biomedical science, and computational 
biology.  These Centers will provide for a national network of investigators 
and will foster an interconnected research approach dedicated to understanding 
the physical, chemical, and biological complexities linking oceans and human 
health.  

To achieve this goal, COHH will support three or more thematically linked 
research projects, facility cores that support two or more projects, an 
administrative core, and pilot projects.  COHH will present opportunities to 
study oceanographic processes and their biological impacts on human health. 

Each COHH should be organized around a central theme that unites all 
components of the Center.  The theme of a proposed COHH may address one of the 
following two possibilities:

o  One of the three special areas of emphasis identified above (HABs; water- 
and vector-borne disease; marine-derived pharmaceuticals and probes).

o  A defined geographical area or ecosystem (e.g., polar regions, urban 
harbors, tropical coastal areas, small islands, estuaries, the Great Lakes) in 
which two or more of the special emphasis areas can be studied.

Identified research needs within the special areas of emphasis include, but 
are not limited to:

A.  HABs

o  Determine the physical, chemical, and biological factors that promote 
blooms and toxin release.  Are there specific conditions, nutrient profiles, 
or physical parameters that support maximal toxin synthesis?  What is the 
nature of the ecological, genetic, and enzymological conditions that confer 
toxigenicity?  Is toxin production constitutive or inducible?  What is the 
natural progression of HAB events?  Do they exhibit toxic potential at all 
stages?  

o  Genomics of harmful algal species should be developed for many 
applications, from improved systematics and molecular detection techniques, to 
determination of the genes controlling toxin production, to developing methods 
to suppress toxicity.     

o Develop new and improve existing methods for identifying the algal species 
responsible for a bloom.  This work should utilize novel, state-of-the-art 
methods in biomedical, chemical, and physical sciences to advance 
significantly our capacity to recognize specific algae-bloom linkages.    

o  Examine molecular mechanisms of action of marine toxins to improve 
detection, develop antidotes, and design new compounds for research tools.  
Are there specific molecular targets that can be exploited for assessment?  
What are the structure/activity relationships that govern interaction with 
molecular targets for each toxin type?

o  Determine toxin levels and environmental conditions at which chronic or 
acute health effects become important.  Only acute rather than chronic health 
effects have been documented in most HAB-related diseases.  Can acute 
poisonings or long-term, low-level exposure to HAB toxins result in chronic 
health effects?  At what level of toxin do chronic or acute effects become 
important, and under what suite of environmental conditions?  

o  Couple oceanographic and biomedical technologies to produce smart sensors 
that detect developing blooms.  This effort should unite biological data with 
relevant ecological and physical data to create innovative strategies and 
processes for early detection and prevention.  In order to develop precise 
analytical detection methods, specifically labeled toxin derivatives are 
necessary.  Designer toxins, developed through organic manipulation, genetic 
manipulation of HAB genomes, and metabolic manipulation through use of 
designer substrates, hold potential for producing many new tools for research 
and diagnostic uses.  Technologies should be refined and improved to target 
detection of toxic strains and to quantify toxins in environmental samples, 
which should be combined with use of remote sampling techniques such as 
automated platforms, drifters, and fixed moorings.

o  Improve exposure and effect assessment through development of new 
biomarkers and their application to population-based studies.  Biomarkers of 
exposure are crucial for diagnosis, treatment, prognosis, and epidemiological 
evaluation of these toxins and their possible human health effects.  Document 
the incidence of toxin-related illnesses in high-risk areas and establish 
cause-effect relationships.  Assess health effects in sensitive 
subpopulations, such as children or persons with underlying neurological or 
immune disease.  Can health effects be mitigated and/or prevented?  Develop 
and evaluate potential molecular therapeutic and antidote candidates.  
B.  Water- and vector-borne diseases

o  Use genomics and proteomics to better understand pathogenicity and survival 
of marine-borne pathogens and to target genetic and immunological detection 
approaches.

o  Develop rapid, accurate, and affordable tests, requiring relatively small 
sample volumes, to detect and quantify various pathogens in water and 
shellfish.

o  Characterize factors controlling pathogen survival in seawater and 
spatial/temporal patterns of dispersal, transport, and partitioning into 
suspended particles and sediments.

o  Assess the value of indicators vs. direct pathogen detection, bacterial and 
viral.  Introduction of newer molecular genetic and immunological methods for 
direct detection of pathogens offers promise.  

o  Evaluate risks of various pathogens (and/or connection to indicators) in 
population-based studies.

o  Apply near-shore physical and geological oceanography to understand 
transport of pathogens where human exposure occurs, for evaluating problems 
with existing systems, and to assist in siting and design of new or 
replacement sewage and runoff outfalls.

C.  Marine-derived pharmaceuticals and probes

o  Develop new approaches in marine cell culture, aquaculture, and biochemical 
methods for production of marine pharmaceuticals.

o  Apply molecular genetics to isolate and express biosynthetic genes and to 
express these pathways in expression hosts for the production of marine 
pharmaceuticals.

o  Design new technologies to facilitate saline cultivation and large-scale 
fermentation of marine microorganisms.

o  Expand exploration of marine plants and animals to less favorable 
environments, e.g., polar oceans and deep ocean environments, and to 
underinvestigated taxonomic groups, e.g., marine microorganisms.

o  Implement novel sampling methods to access marine organisms for biomedical 
investigation.

o  Screen marine compounds and derivatives for potential pharmaceutical value, 
particularly for neurodegenerative, cardiovascular, and infectious diseases.

DESCRIPTION OF A CENTER

Centers established under this RFA will have in common support for the 
following four basic elements: research projects; an administrative core; 
pilot projects; and facility cores.  For the purpose of this RFA, a Center for 
Oceans and Human Health (COHH) is defined as an interdisciplinary 
collaborative arrangement among a group of scientists located at the same or 
different institutions, committed to conducting at least three individual but 
interrelated and interdependent research projects that address the goals of 
this RFA.  Plans for interaction among the components within Centers must be 
explicitly described.

A.  Research Projects

Each Center will minimally support three meritorious research projects with a 
conceptual theme focusing on oceans and human health.  Research projects must 
be interdisciplinary and address one or more of the identified special 
emphasis areas (HABs; water- and vector-borne disease; marine-derived 
pharmaceuticals and probes).  Research projects should unite the skills of 
basic and clinical biomedical scientists with physical, chemical, and 
biological oceanographic scientists.  A Center will be asked to describe a 
plan for promotion and support of interdisciplinary planning, implementation 
and synthesis of research across and within individual projects. 
 
Hypotheses and specific aims developed and described for research projects 
must demonstrate the thematic, interdisciplinary, and collaborative nature of 
the Center proposal. This requirement is meant to promote interdisciplinary 
collaboration in development and design of Center research projects as well as 
continued collaboration throughout the duration of Center support.

B.  Administrative Core

The administrative structure should include, in addition to the Center 
Director, a Co-Director, a business manager, an internal steering committee, 
and an external advisory committee.  The Director and Co-Director should
possess complementary expertise in biomedical and oceanographic sciences.  An 
individual with expertise in either field can be Director or Co-Director.  
Both fields should be covered by the Director and Co-Director team.  The 
external advisory committee should consist of a group of three to five 
scientists, having expertise appropriate for the Center's research focus, who 
are outside the applicant institution.  The membership of the advisory 
committee must be approved by the Participating Agencies post review.  Names 
should not be submitted in the application.  Individuals in senior leadership 
positions should provide intellectual, administrative, and scientific 
leadership for the Center and are critical to its overall effectiveness and 
evolution.  These individuals should be in place and committed to a defined 
percent effort.  

The administrative core should promote joint planning and evaluation 
activities as well as collaborations and interactions among different 
components of the Center.  The Center must have appropriate and adequate 
management capabilities to conduct research and to evaluate the performance of 
the Center in achieving the goals of the RFA.  Objective criteria for 
evaluation, including intermediate markers for assessing the impact of the 
science conducted by each Center in elucidating connections between the oceans 
and human health, are required as part of this core.  

In addition, each Center should describe a mechanism for data sharing and 
technology transfer with other Centers and with potential end users of 
research results, such as state public health and environment agencies. 

It is anticipated that a Center will devote no more than 10 percent of its 
budget to the administrative core.

C.  Pilot Project Program

Funds can be used to provide support for short-term research projects to 
explore the feasibility of new areas of study and to enable investigators to 
collect preliminary data for other funding mechanisms.  Centers may provide up 
to $200,000 per year in direct costs for pilot projects, which based on 
internal peer review, are deemed to have a high potential to lead to more 
fully developed, competitive research projects.  The process of internal peer 
review must be specified in the application.  General conceptual examples of 
two proposed pilot studies should be given; but details of the content of 
pilot studies are not required.  Scientific merit of pilot projects should be 
evaluated based on the potential to address research gaps in the scientific 
focus of the Center.  Management of the program must include a means of 
announcing its availability, a mechanism of scientific merit review, and a 
record of results.  This record must be available to Government program 
directors for review post-award.  

D.  Facility Cores

Centers may support shared core resources common to two or more research 
projects.  Each Center may support facility cores that provide a technique, 
service, or instrumentation to enhance ongoing research efforts.  Examples of 
such facilities include: biostatistics and/or bioinformatics, genomics and 
proteomics, exposure assessment, and sensor development.  Budgeted Center 
projects as well as research projects external to the Center may have access 
to facility cores.  The application should provide a total operational budget 
for each facility core together with the percentage of support requested from 
the Center grant.  The application should explain the organization and 
proposed mode of operation of each core, including a plan for usage, priority 
setting, allocation of resources, and any applicable charge back system.  
Allocation among various components of the Center should be balanced and well 
justified.

SPECIAL REQUIREMENTS 

Interaction among different Centers could contribute significantly to the 
objectives of this initiative.  Centers are encouraged to describe creative 
strategies for fostering inter-Center collaborations, data sharing, technology 
transfer, and for identifying overarching scientific and methodological 
issues.  COHH Principal Investigators and each research project and core 
facility leader from each Center will be required to attend an annual meeting 
in the Washington, DC metropolitan area, and Research Triangle Park, NC (in 
alternating years).  The travel budget should therefore reflect appropriate 
allocation for this activity.  The purpose of these annual meetings will be to 
share scientific information, assess progress, identify and solve common 
methodological problems, identify new research opportunities, and consider 
possible strategies for evaluating progress.

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Allen Dearry, Ph.D., Chief
Chemical Exposures and Molecular Biology Branch
National Institute of Environmental Health Sciences
P.O. Box 12233
111 T.W. Alexander Drive, MD EC-21
Research Triangle Park, NC 27709
Telephone:  (919) 541-4943
FAX:  (919) 316-4606
Email:  dearry@niehs.nih.gov

Donald L. Rice, Ph.D., M.P.H., Director
Chemical Oceanography Program
Division of Ocean Sciences
National Science Foundation
4201 Wilson Boulevard
Arlington, VA 22230

Telephone:  (703) 292-8582
FAX:  (703) 292-9085
Email:  drice@nsf.gov

o Direct your questions about peer review issues to:

Linda K. Bass, Ph.D.
Scientific Review Administrator
Scientific Review Branch
National Institute of Environmental Health Sciences
P.O. Box 12233 (MD EC-30)
111 T.W. Alexander Drive
79 T.W. Alexander Drive, Bldg 4401, Room 3172 (express/courier service)
Research Triangle Park, NC 27709 
telephone:  (919) 541-1307
fax:  (919) 541-2503
Email:  bass@niehs.nih.gov
 
o Direct your questions about financial or grants management matters to:

Ms. Laura Williams-Boyd
Grants Management Specialist
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233 (MD EC-22)
111 T.W. Alexander Drive
Research Triangle Park, NC 27709 
Telephone:  (919) 541-7629
FAX:  (919) 541-2860
Email:  Willia27@niehs.nih.gov

LETTER OF INTENT

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

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

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows Participating Agency staff to estimate the potential review 
workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:

Linda K. Bass, Ph.D.
Scientific Review Administrator
Scientific Review Branch
National Institute of Environmental Health Sciences
P.O. Box 12233 (MD EC-30)
79 T.W. Alexander Drive, Bldg 4401, Room 3172 (express/courier service)
Research Triangle Park, NC 27709 
Telephone:  (919) 541-1307  Fax:  (919) 541-2503
Email:  bass@niehs.nih.gov

SUBMITTING AN APPLICATION

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

For projects requiring oceanographic research platform support through the 
University-National Oceanographic Laboratory System (UNOLS), the Principal 
Investigator should submit a request to the UNOLS Office at www.unols.org no 
later than March 1 of the year prior to the year of the first cruise.   A copy 
of the UNOLS request must be appended as an appendix at the end of the 
application.

SUPPLEMENTAL INSTRUCTIONS

The body of the scientific application will be composed of the following 
sections with the appropriate page limitations:

- Introduction and organization of the Center - 5 pages maximum
- Administrative Core - 15 pages maximum
- Research Projects - 25 pages maximum each
- Pilot Project Program - 10 pages maximum
- Facility Cores - 15 pages maximum 
- Appendices 

Human subjects and animal welfare issues should be addressed in each of the 
appropriate sections.  Discussions of these issues will not be subject to the 
page limitations.  An overall Center description, list of all performance 
sites, and list of all key personnel (i.e., PHS 398 Form Page 2) should be 
included at the beginning of the application.  Appropriate budget pages for an 
overall consolidated Center budget, including consortium or contractual 
arrangements, should appear at the beginning of the application.  Budget 
pages, personnel descriptions, and biosketches specific to Research Projects 
and Facility Cores should be incorporated in the appropriate sections.  All 
appendices should be labeled appropriately and should appear at the end of the 
proposal, after the checklist. Applications not organized in this manner may 
be returned without review.

USING THE RFA LABEL

The RFA label available in the PHS 398 (rev. 5/2001) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line 2 of the face page of the application form and the YES box must be 
marked.  The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed, photocopies, in one package to:

Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

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

Linda K. Bass, Ph.D.
Scientific Review Administrator
Scientific Review Branch
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive, Bldg 4401, Room 3172 (express courier)
Research Triangle Park, NC 27709 
Telephone:  (919) 541-1307
FAX:  (919) 541-2503
Email:  bass@niehs.nih.gov

APPLICATION PROCESSING

Applications must be received by the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will 
be returned to the applicant without review.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an Introduction addressing the previous critique.

PEER REVIEW PROCESS  

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIEHS and NSF.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NIEHS in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will:

o Receive a written critique

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score.

o Receive a second level review by the National Advisory Environmental Health 
Sciences Council and NSF Board. 

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
goals of NSF-supported research are to advance the national health, 
prosperity, and welfare.

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

A.  Research Projects

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

o  Significance.  Does your study address an important problem? If the aims of 
your application are achieved, how do they advance scientific knowledge?  What 
will be the effect of these studies on the concepts or methods that drive this 
field?

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

o  Innovation.  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?  Does the 
study reflect sufficient originality, novelty, and innovation to make it 
highly relevant to the overall goals and objectives of COHH?

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

o  Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed projects take 
advantage of unique and interdisciplinary features in the scientific 
environment and reach out to useful collaborative arrangements?  Is there 
evidence of adequate institutional support?  Is the project interactive with 
and supportive of other components of the COHH conceptually and 
experimentally?  

B.  Facility Cores  

o  Evaluate overall use of each core by research projects. Determine whether 
projected use is sufficient to warrant establishment of the core.  Determine 
if the usage is balanced and broadly based.

o  Evaluate the core for its overall importance to research activities in the 
Center. Evaluate whether the core is likely to become of greater or lesser 
importance to Center members in the future.  Determine if the facility core 
can contribute to expansion of research into new areas.

o  Evaluate whether there is sufficient institutional commitment to meet the 
requirements of the core.

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

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

o  Assess the total operational budget of the facility core and the percentage 
of support requested from the Center grant and determine if the facility core 
usage by Center members is proportional to support requested.

o  Adequacy of the justification for specialized resources relative to its 
essential need for the conduct of COHH research or pilot projects.

o  Adequacy of qualifications and performance (if applicable) of core 
personnel to conduct high quality, reliable resource operations.

o  Adequacy of plans for oversight of resources and prioritization of work. 

C.  Administrative Core

o  Evaluate whether the lines of authority and the administrative structure 
are designed for effective Center management.

o  Evaluate the qualifications, responsibilities, and effectiveness of senior 
leaders. Identify if the percent effort is appropriate.

o  Evaluate the duties and percent efforts of administrative staff of the 
Center in terms of their qualifications and contributions to the specialized 
needs and conduct of the Center's research activities.

o  Evaluate the effectiveness of the Center's internal planning and evaluation 
activities.  Determine who is involved and the mechanisms used.  Determine if 
these activities are documented.  Determine if Center members have input into 
decision-making; if so, how.

o  Evaluate how well the administrative structure maximizes the Center's 
capability to take advantage of research opportunities.

o  Assess the strategy and effectiveness of plans for sharing of data, 
technologies, and products with other Centers and with potential end users. 
 
D.  Pilot Project Program

o  Evaluate whether pilot project funds will be used to test innovative ideas 
of particular importance to the development of new ideas within the COHH.

o  Evaluate the review process used by the Center to distribute funds for 
pilot projects.

o  Evaluate the overall plan for and potential effectiveness of the pilot 
project program in filling gaps in research areas relevant to the scientific 
focus of the COHH.

o  Evaluate the adequacy of the proposed process for continuously reviewing 
and funding a spectrum of pilot projects for their quality, innovation, 
interdisciplinary nature, and importance to oceans and human health research.

o  Evaluate the degree to which pilot project funds will be used to stimulate 
projects of an interdisciplinary nature that will promote collaborative 
interactions within the Center.

o  Evaluate the appropriateness of the budget relative to the scope of the 
proposed pilot project program and potential of the program to generate 
innovative pilot projects on a consistent basis.

E.  Overall Program Organization and Capability

Centers must include three or more research projects with a conceptual theme 
focusing on one of the two thematic areas outlined in the RFA.  There must be 
evidence of the potential for a meaningful interdisciplinary collaboration 
with an integrated identity relevant to oceans and human health.  

o  Evaluate the overall programmatic structure of the Center=s research 
capability.

o  Evaluate whether the organization of the Center is structured and managed 
in a way that maximizes scientific productivity.

o  Evaluate the interdisciplinary nature of the proposed research activities, 
integration of the projects around an overarching theme, and plans to 
effectively pursue interdisciplinary research objectives.

o  Evaluate the strength of the procedures, processes, and plans for promoting 
interdisciplinary interactions, including coordination, interaction, 
collaboration, and synthesis.

o  Evaluate the strength of plans for synergistic and effective collaborations 
within the Center.

F.  Institutional Commitment

o  Evaluate the effectiveness of the Center as a formal organizational 
component within the institution relative to other organizational components. 
 Determine whether the reporting, accountability, and management structure of 
the COHH within the institution are equivalent to that of comparable 
organizations within the institution.  Adequacy of institutional procedures 
and plans for monitoring, evaluating, and assuming accountability for the 
general success of the COHH.

o  Evaluate the specific resources provided by the institution such as 
personnel, appropriate facilities, financial support, and other forms of 
support that reflect the level of the institution's commitment to the 
functional stability, continuing development, and success of the Center.

o  Adequacy of the institutional infrastructure for assessing progress and 
needs. 

ADDITIONAL REVIEW CRITERIA

In addition to the above criteria, your application will also be reviewed with 
respect to the following:

o  PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

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

o  DATA SHARING: Adequacy of the proposed plan to share data.

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

Overall Evaluation and Scoring of the Application

A single numerical priority score will be assigned to the COHH application as 
a whole after discussing all of the review elements listed above.  The score 
will be based on the overall quality of the research projects, administrative 
core, pilot project program, facility cores, institutional commitment, and 
overall program organization and capability.  Primary emphasis will be placed 
on scientific merit. 

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: February 17, 2003
Application Receipt Date: March 17, 2003  
Peer Review Date:  June, 2003
Council Review:  September, 2003
Earliest Anticipated Start Date:  September 30, 2003

AWARD CRITERIA

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.

REQUIRED FEDERAL CITATIONS 

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported 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 AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm 
The amended policy incorporates: the use of 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 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

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

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at  
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

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

HUMAN EMBRYONIC STEM CELLS (hESC)

Criteria for federal funding of research on hESCs can be found at 
http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). 
 It is the responsibility of the applicant to provide 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. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA. 
 It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

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

NSF advocates and encourages open scientific communication. NSF expects 
significant findings from supported research and educational activities to be 
promptly submitted for publication with authorship that accurately reflects 
the contributions of those involved. It expects Principal Investigators to 
share with other researchers, at no more than incremental cost and within a 
reasonable time, the data, samples, physical collections and other supporting 
materials created or gathered in the course of the work. It also encourages 
grantees to share software and inventions, once appropriate protection for 
them has been secured, and otherwise act to make the innovations they embody 
widely useful and usable. 

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 http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.113, 93.115, 93.866, and 47.050 (Geosciences) and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301, 
405, and 1861 of the Public Health Service Act as amended (42 USC 241 and 284) 
and administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

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.

Return to Volume Index

Return to NIH Guide Main Index

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.