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 https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, 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: https://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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 https://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 https://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 https://grants.nih.gov/grants/stem_cells.htm and at https://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 https://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 https://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.

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