Full Text ES-94-007 SUPERFUND HAZARDOUS SUBSTANCES BASIC RESEARCH PROGRAM NIH GUIDE, Volume 23, Number 8, February 25, 1994 RFA: ES-94-007 P.T. 34 Keywords: Environmental Health Environmental Effects National Institute of Environmental Health Sciences Letter of Intent Receipt Date: April 18, 1994 Application Receipt Date: June 17, 1994 PURPOSE The National Institute of Environmental Health Sciences (NIEHS) is proposing the continuation of a special Program of basic research and training grants directed towards understanding, assessing, and attenuating the adverse effects on human health resulting from exposure to hazardous substances. Grants made under the Superfund Hazardous Substances Basic Research and Training Program [Superfund Basic Research Program (SBRP)] will be for coordinated, multicomponent, interdisciplinary programs, and the objective is to establish and maintain a unique Program linking biomedical research with related engineering, hydrogeologic, and ecologic components. The Superfund Amendments and Reauthorization Act (SARA) of 1986 established a university-based program of basic research within the NIEHS to complement existing activities within the U.S. Environmental Protection Agency (EPA), the principal manager of the Superfund Program, and the Agency for Toxic Substances and Disease Registry (ATSDR). The EPA has specific mandated research responsibilities in the area of hazardous substances at hazardous waste sites; hazardous waste containment and destruction technologies; and environmental transport and fate of chemicals; as well as for monitoring and testing for hazardous substances in the environment. The ATSDR provides site-specific, public health assessments and advisories to the EPA and to state and local agencies, citizens, and health care providers. Its research mission includes applied research into the development and evolution of toxicologic profiles of hazardous substances found at Superfund sites and the assurance that toxicologic testing of these substances is conducted when necessary. The SARA legislation specifically mandates that the basic research program administered by NIEHS include the following: o Methods and technologies to detect hazardous substances in the environment. o Advanced techniques for the detection, assessment, and evaluation of the effects on human health of hazardous substances. o Methods to assess the risks to human health presented by hazardous substances. o Basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances. Accordingly, the NIEHS will support projects in the areas of engineering, ecological, and hydrogeological research as long as they are to be performed in conjunction with biomedically related components. The NIEHS has encouraged true collaborative efforts among researchers in these various areas, and hopes to continue this endeavor. While emphasizing the necessity for a strong biomedical core, it intends that the non-biomedical projects will be an integral part of the overall effort and not a support or core function. The NIEHS is committed to research that seeks to understand the impact of exposures to hazardous substances in all populations, including those that are composed of minority and economically disadvantaged persons. It would be useful, in defining the problem in disadvantaged populations, to understand those issues of environmental justice as pertains to the health effects associated with living in proximity to hazardous wastes sites, as well as describing the detrimental health effects of such exposures, including associated psychological, social, and cultural consequences. Description of the Program The NIEHS SBRP is intended to support a wide range of research to address the broad public health concerns arising from the release of hazardous substances and hazardous wastes into the environment, particularly from uncontrolled, leaking waste disposal sites. Although some of the research currently supported by NIEHS is relevant to these concerns, the SBRP is distinct in that its primary objective is to expand the base of scientific knowledge, reduction in the amount and toxicity of hazardous substances, and, ultimately, prevention of adverse human health effects. The research sponsored in the fields of ecology, engineering, and hydrogeology (designated collectively as non-biomedical research) integrated into a biomedical research program core is designed to provide a broader and more detailed body of scientific information to be used by state, local, and Federal agencies and by private organizations and industry in making decisions related to the management of hazardous substances. Presently, the Program funds 18 grants at 29 universities and institutions encompassing 142 individual research projects involving more than 1050 scientists and technical staff addressing its legislated mandates. Many or all of these programs will be submitting applications for the competitive renewal of their grant. Nonetheless, this competition is open to all institutions meeting the criteria under this Request for Applications (RFA). The SARA legislation establishing the NIEHS SBRP authorized funding levels of $3 million in Fiscal Year 1987, $10 million in 1988, $20 million in 1989, $30 million in 1990, and $35 million in 1991 through 1994. The appropriated amounts for this Program have increased from $3 million in FY 87 to $32.9 million in FY 94. Any dollar amounts projected for this Program are budget ceilings and actual amounts will be appropriated each year according to the Federal budget process. Because the funding level of this Program may vary from that authorized, actual award levels for approved and funded applications will be based on program balance and the availability of funds, in addition to the scientific merit considerations of the review process. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000", a PHS-led national activity for setting priority areas. This RFA, Superfund Hazardous Substances Basic Research Program, is related to the priority area of environmental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202)-783-3238). ELIGIBILITY REQUIREMENTS Section 311(a)(3) of SARA limits recipients of awards to "accredited institutions of higher education," which are defined in the Higher Education Act, 20 USC (annotated) 3381. However, grantees are permitted under the law, and encouraged by NIEHS, to subcontract as appropriate with an organization, public or private, necessary to conduct portions of the research. These organizations may include generators of hazardous wastes, persons involved in the detection, assessment, evaluation, and treatment of hazardous substances, owners and operators of facilities at which hazardous substances are located, and state and local governments. MECHANISM OF SUPPORT The mechanism of support will be the hazardous substance basic research (P42) multiproject grant for a period not to exceed five years. Grants funded under this Program must be multiproject, interdisciplinary efforts bringing together a group of investigators to direct discrete research projects, each of which is related to the goals of the SBRP. In addition to the research projects, applicants may request funds to support core facilities and common support functions such as administrative support, shared equipment, and analytical services. Applicants are expected to furnish their own estimates of the time required to achieve specific objectives of the proposed work, a schedule for completion of the work, and an outline of the segments into which the proposed program can be logically divided. The applicant and co-investigators will plan, direct, and execute the research program, but any substantial modifications in the scope or objectives must be mutually agreed upon by the grantee institution and the NIEHS. Because a variety of approaches will be responsive to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. Similarly, budgetary reductions may necessitate limiting the amount of awards, making adjustments in budget and/or effecting a modification in the scope of proposed work, prior to funding. Unless specifically stated otherwise, all policies and requirements that govern the grants program of the Public Health Service will prevail. FUNDS AVAILABLE This Program is being resolicitated under the assumption that funds available will at least be equal to those of the current fiscal year (FY 94, $32.9 million) or possibly the present authorized level of $35 million. For planning purposes, the NIEHS estimates the funds (total costs) available for this solicitation for the first year of support for the entire Program is the present authorized level of $35 million dollars. The expected range of number of awards is 15 to 20. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this Program is provided for in the financial plans of NIEHS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Research Goals The NIEHS SBRP is intended to foster the growth of collaborative multidisciplinary research programs aimed at understanding health and environmental effects associated with hazardous waste sites, and at developing improved technologies for cleaning up these sites. The focus of the Program is the effects on human health. The Program's approach primarily emphasizes the use of advanced basic research to improve the sensitivity and specificity of techniques for detecting adverse effects in humans or in ecological systems. Research objectives can be divided, but are not limited to, the broad areas described below: o Studies on the effect of hazardous substances on cellular and molecular biological processes. o Studies to assess the impact of toxic chemicals on the reproductive system including hormone production, end-organ responsiveness, germ cell biology, maturation (puberty), senescence (menopause), fertility, fecundity, ectopic tissue production and oncogene expression in reproductive tissues. o Studies on the effects of toxic agents on immune competence as it relates to cellular and humoral responses and immune-endocrine interactions (stress). o Studies of potential effects of low-level chronic exposure to toxic chemicals on susceptibility to age-related deterioration by oxidative free radicals or to endogenous neuroexcitatory chemicals. o Studies of behavioral, neurological and neuroendocrinological effects of toxic chemical exposures, especially to chronic/delayed exposures to low levels. o Analysis and evaluation of pollutant impact on toxicity endpoints, especially effects on the respiratory, renal and cardiovascular systems, on the integument (skin), and on hearing and vision. o Development of methods and techniques for the quantification and analysis of hazardous substances. o Development of methods to detect the lowest concentrations of chemicals that could pose toxic threats to humans; establishment of dose-response relationships for pollutants likely to be found in the environment. o Analysis and studies of specific toxic agents, such as metals, and simple and complex mixtures. o Epidemiologic studies of health effects associated with exposure to hazardous substances. Endpoints of interest include neurologic, renal, respiratory and reproductive effects including congenital malformations, immune dysfunction, and cancer. Development of new statistical and exposure assessment methods to tackle these problems is encouraged. o Assessment of health risks by utilizing validated biomarkers of exposure and effect in human populations exposed to sources of hazardous substances. Development and validation of new biomarkers for non-cancer endpoints is desired. o Studies on the use of markers of genetic susceptibility to determine increased risk of health effects in population subgroups exposed to toxic substances associated with hazardous wastes. o Studies investigating the improvement and validation of risk assessment models. Improvement of the scientific data and the methods used to make remediation and policy decisions, especially in biologically based risk assessment, is needed. o Studies investigating exposure to hazardous substances in sensitive populations. For example, basic research and epidemiologic studies designed specifically to address the environmental factors effecting children's health and well-being; studies dealing with the differing sources of exposure for children vs. adults and questions pertaining to dose and pharmacokinetics of metabolism and clearance of toxins in children; studies of the latent health effects of these childhood exposures later in life. o Studies to evaluate potential age-related, gender-specific and race-directed consequences of toxic chemical exposures. o Studies involving multiple chemical sensitivity to low level exposures. Studies determining whether there is a group of susceptible individuals who respond adversely to very low levels of environmental chemicals and how they respond. o Studies on the effect of hazardous substances on ecological systems, especially those related to ecological succession within various ecosystems and the impact toxic substances may have on the natural course of succession as well as on biodiversity; studies related to sentinel species model development; studies designed to study the resistance and resilience to the impact of toxics and leachates on ecosystems. o Studies in molecular ecotoxicology, specifically the integration of genetic ecotoxicology, ecological genetics, and molecular biology. Investigations on the development and use of genetic toxicology as it applies to protecting and assessing the integrity of ecosystems; investigations to improve our understanding of the ecological implications of short-term genotoxic responses, specifically by defining the linkages to the field of ecological genetics and to population- and ecosystem-level ecological theory; investigation into the critical evaluation new molecular genetic techniques as tools in both genotoxicity assessment and ecological genetics. o Studies pertaining to the food web, such as the development of model systems to look at the effects of chemicals on the food web; studies to increase our understanding of the role of bioavailability in human health. o Studies related to groundwater as a major route of human exposure; development of methods to examine all forms of contamination of unconfined and confined aquifers, and the development of remediation methods to clean up contaminated aquifers; research into the complexities of the subsurface flow patterns, the physical-chemical characteristics of the chemicals that have contaminated the aquifer, and the population characteristics of microorganisms at different locations within the subsurface that are involved in biochemical transformation. o Studies in the area of fate and transport of chemicals through various media from hazardous waste sites. Improvement of techniques needed for measuring and modeling movement and alteration of chemicals through the media surrounding the hazardous substances waste site. Research in the validation of hydrogeologic models that have been developed is encouraged, as are studies determining the bioavailability of these chemicals as it relates to their fate and transport. o Studies pertaining to the area of combustion engineering. For example, investigation of new state-of-the-art methods of incineration, optimal operational parameters, formation of toxic by-products from combustion, and expansion of research into the health effects of exposure to combustion by-products. Studies of various physical and chemical parameters involved in thermal treatment and degradation of hazardous substances; the development of real-time monitors to determine the level of emissions in the combustion/pyrolysis process; basic methods to increase the efficiency of combustion and pyrolysis. o Continued and increased investigation of alternatives to thermal destruction, including biological conversion, chemical conversion or neutralization, and new destructive techniques; development of new and advanced techniques in biodegradation, especially of recalcitrant chemicals, simple and complex mixtures, and metals. o Studies related to biodegradation/bioremediation of hazardous substances. Studies on the development of systems capable of a wide range of degradation as well as the development of existing and new bioreactors (scaleup) for remediation. Studies related to the sequestering of metals by microbes as well as the conversion of these metals into less toxic forms is encouraged as these approaches show promise in dealing with these nondegradable substances. Studies on the use of genetically engineered higher plant species to remediate toxic waste sites. In addition, the investigation of the fate of various environmental toxins in plants and the chemical modifications as they enter the environment through mediation of higher plants. o Studies on the minimization of hazardous substances at the source through efficiently engineering better production processes as well as reducing waste streams; development of zero/low emission technology as means to reduce the amount and/or toxicity of hazardous substances. The above examples of research opportunities are only illustrative of the types of research efforts that may be appropriate to this program and are not meant to be all-inclusive or restrictive. Nonetheless, it is important that investigators submitting an application under this RFA propose multidisciplinary studies that are integrated and designed to produce results in the toxic waste area, primarily in assessing, evaluating, and attenuating the adverse effects on human health resulting from hazardous substances. To better coordinate NIEHS SBRP activities with the U.S. Environmental Protection Agency, Office of Solid Waste and Emergency Response (OSWER), OSWER has provided the NIEHS with a list of 22 chemicals of specific interest to their Superfund cleanup efforts. These chemicals are among those also identified by ATSDR in their 1992 Priority List of Hazardous Substance (Federal Register October 28, 1992 57FR48801). It is recommended that applicants include any of these chemicals in their application if an where appropriate to their individual research goals. The chemicals of particular interest to OSWER are: lead 1,1,2-trichloroethylene toluene chromium benzene tetrachloroethene arsenic 1,1,1-trichloroethane cadmium zinc chloroform polychlorinated biphenyl copper xylene ethylbenzene 1,2-trans-dichloroethylene mercury phenol 1,1-dicloroethane methylene chloride 1,1-dichloroethene nickel The NIEHS encourages potential applicants to use institutional strengths and ideas to prepare applications directed towards the broad goals of the Program as stated above. The intent is to create an environment in which various groups of scientists can interact, exchange ideas, and proceed efficaciously towards solving the complex problems of understanding, assessing, and attenuating risks to human health from hazardous substances. Strong biomedical research is a requisite of this Program. Therefore, a minimum of three approved biomedical projects is required for funding. Further, the Program expects that the non-biomedical research will be an integral part of the overall effort. All applications considered for funding must contain approved projects in both biomedical and non-biomedical areas. Furthermore, the number of projects, excluding cores, proposed should not exceed 10. Exceptions may be made following justification and discussion with Program staff. Training An area of importance to the overall performance of the Program, and to the future of environmental health research, in general, is training. The NIEHS intends to support graduate and advanced training in environmental and occupational health and safety and the engineering aspects of hazardous waste control, and in geosciences (including hydrogeology, geologic engineering, geophysics, geochemistry, and related fields) in the setting of the research program. Therefore, applicants are encouraged to propose specific plans for interdisciplinary training as part of their overall program. The NIEHS encourages potential applicants to develop a structured, interdisciplinary pre-doctoral training program within an established training core. The training core should aid in the integration of the overall research effort. Of special interest are positions in the non-biomedical projects to train scientists and engineers in the context of an interdisciplinary program. Additional training of pre- and post-doctoral students may also be carried on outside the structured training program. In keeping with the National Institutes of Health (NIH) efforts to train members of minority groups in its ongoing training programs, applicants are encouraged to consider these candidates in their recruitment efforts. Individuals in the training positions must be considered employees of the institution and not trainees receiving stipends as in the NIH National Research Service Award programs. Salaries and fringe benefits consistent with institutional policies may be requested. Funds may also be requested for tuition, where appropriate, and travel to one scientific meeting per year. Up to six percent of the total direct costs requested may be identified for this purpose. Outreach: Information/Technology Transfer In order to make informed decisions concerning management of hazardous substances, there exists a need to make available information gained from studies completed by this Program. Therefore, the NIEHS supports the development of outreach projects for communicating pertinent results to industry, federal, state and local government and to the public. All multicomponent programs (P42s) are encouraged to include at least one core component addressing outreach. The NIEHS SBRP defines outreach projects to be interactions with community, government and/or industry (including technology transfer). Outreach activities should be consistent with the research strengths of program, and should not exceed 10 percent or $100,000, whichever is less, of the cost of the program. Should outreach be a core component, an evaluation element needs to be included in order to measure the effectiveness of this core. Community Outreach The NIEHS encourages the involvement of the programs with community groups. There is a public health need to link members of the community with environmental health and environmental technology researchers. For example, outreach cores may consist of impacting public awareness (i.e., understanding the health effects, as well as associated psychological, social and cultural consequences, of such exposures), disease prevention programs, health professional training (i.e, training of pediatricians in environmental health), primary, secondary and college general education, and community issue programs. Governmental Outreach The NIEHS encourages the interaction of the programs with local, state and federal government agencies. For example, information gained from the NIEHS SBRP in dealing with potential health risks of preexisting land conditions may influence decisions by state and local government concerning land utilization. In addition, NIEHS supports the interaction of programs with other governmental agencies involved in environmental health and/or environmental technologies such as the regional offices of the EPA, the EPA Superfund Innovative Technology Evaluation (SITE) Program, and state departments of health and/or environmental resources. Industrial Outreach (Technology Transfer) In order for waste sites to be managed and remediated effectively, new methods and techniques must be developed to detect, assess and monitor human health and environmental effects of toxic substances. The Program is designed to expand the base of scientific knowledge concerning the issues of hazardous substance management by filling gaps in existing technology. The process of technology transfer is an essential step in the development and application of innovative hazardous substance management technologies. A technology transfer core component should facilitate the management and exchange of technical information and data generated by the program. Within available resources, NIEHS will provide assistance for the transfer of technology and information from the laboratory to the field. As research progresses, programs will need to discuss with NIEHS program staff any technology information which could have the potential for use on an expanded scale. External Advisory Committee The NIEHS strongly recommends the formation of an external advisory committee for each multicomponent program. The primary function of this group should be to review program activities and make recommendations to investigators for future research and training directions consistent with the objectives of the SBRP. SPECIAL REQUIREMENTS In addition, it is anticipated that grantees under this Program will be requested to meet annually. Applicants may budget funds for appropriate staff to attend a three-day annual meeting in Research Triangle Park, NC, or Washington, DC. Animal Welfare Considerations Investigators are encouraged to consider alternative methods and approaches in their research applications that do not require the use of whole animals, that use alternative species such as nonmammals or invertebrates, that reduce the number of animals required, and that incorporate refinements to procedures that will result in the elimination of further minimization of pain and distress to animals. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, general and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS-398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. The NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed and the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. The NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by April 18, 1994, a letter of intent that includes the overall title of the proposed research, and a descriptive title of each of the proposed research projects that will be included in the application. Also provide the name, address and telephone number of the Principal Investigator, the identities of other key personnel and consultants, the participating institutions, and the number and title of the RFA to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent application, the information that it contains is helpful in planning for the review of applications. It allows NIEHS staff to estimate the potential review work load and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ethel B. Jackson, D.D.S. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7826 FAX: (919) 541-2503 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 710-0267 (single copy) or (301) 594-7378 (multiple copies). The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Since the PHS 398 is used primarily for the traditional research grant applications, several sections must be modified and expanded so that this form can be used to provide the additional information needed for the Superfund Program applications. Applicants must request a copy of the Information Bulletin on Program Project Grants and special instructions for this RFA application from Dr. William A. Suk at the address listed under INQUIRIES. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-4500 In addition, two signed copies must also be sent or delivered to: Ethel Jackson, D.D.S. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 104 T.W. Alexander Drive Research Triangle Park, NC 27709 Applications must be received by June 17, 1994, at the DRG, and the NIEHS. REVIEW CONSIDERATIONS The NIEHS will identify non-responsive applications and return them to the applicant. Following staff review for responsiveness, applications will be reviewed and evaluated by a group of predominantly non-Federal consultants with expertise in fields relevant to the innovative research NIEHS is seeking to encourage. Based on the large number of complex applications expected, applicants will not be site-visited. Therefore, it is essential that all information required for an adequate and thorough review be included in the application. Applications that are complete and responsive may be subjected to a preliminary evaluation by a peer review group to determine their scientific merit relative to the other applications received in response to this RFA. As a result of this triage process, the NIEHS will withdraw from further consideration applications judged to be noncompetitive and promptly notify the Principal Investigator/program director and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit. The NIEHS will conduct an intensive review on the group of most competitive applications. The review group(s) will be convened by NIEHS to review these applications. A second level of review will be performed by the National Advisory Environmental Health Sciences Council. The major factors to be considered in the evaluation of responsive applications will include: o the scientific merit of each proposed project, including the novelty, originality, and feasibility of the approach, and the adequacy of the experimental design; o the technical merit and justification of each core unit; o the competence of the investigators to accomplish the proposed research goals, their commitments, and the time they will devote to the program; o the scope of the overall effort in relation to the objectives of the Program to create unique interdisciplinary programs to include not only biomedical components, but also engineering, ecological, and/or hydrogeological components; o relevance of the proposed research to problems associated with hazardous waste substances; o the adequacy of the facilities to perform the proposed research; o in those of instances of competitive renewal, the progress of the program to date; o the integration of the various projects and core units into an effective program and plans for interactions among investigators; o the qualifications, experience, and commitment of the Principal Investigator, the ability to devote adequate time and effort to provide effective leadership; o the scientific and administrative structure of the program and integration of the projects into an effective overall effort; o the adequacy and commitment of institutional resources to administer an integrated, collaborative program; and o the appropriateness of the budget for the proposed program. Because the objective of this Program is to create unique, interdisciplinary institutional programs addressing the special needs of Superfund, the review process will concentrate on the strengths and weaknesses of the overall program proposed. Individual projects will be reviewed in light of their contribution to the entire research effort. AWARD CRITERIA The anticipated date of award is April 1, 1995. The following will be considered in making funding decisions: o quality of proposed programs as determined by peer review; o availability of funds; and o program balance among research areas of the announcement. INQUIRIES The NIEHS staff welcomes the opportunity to clarify any issues or questions from potential applicants. Written and telephone inquiries concerning the objectives, scope, and application procedures for this RFA or inquiries about whether specific proposals would be responsive are encouraged and may be directed to: William A. Suk, Ph.D., M.P.H. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-0797 FAX: (919) 541-2843 Questions of an administrative or fiscal nature may be directed to: Ms. Dorothy Williams Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-2749 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.143, NIEHS Superfund Hazardous Substances Basic Research and Education Grant Program. Awards will be made under the authority of the Superfund Amendments and Reauthorization Act of 1986, Title 1, Section III, and Title II, Section 209 (Public Law 99-499); and Public Health Service Act, Section 301 (Public Law 78-410, as amended), and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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