BREAST CANCER AND THE ENVIRONMENT RESEARCH CENTERS RELEASE DATE: November 11, 2002 (see addenda NOT-ES-03-004, NOT-ES-03-006) RFA: ES-03-001 Update: The following update relating to this announcement has been issued: November 18, 2009 - See Notice NOT-ES-10-001 Clarification of Eligibility as Primary Applicant. October 23, 2009 - This RFA has been reissued as (RFA-ES-09-008). National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov) National Cancer Institute (NCI) (http://www.nci.nih.gov) Letter of Intent Receipt Date: December 31, 2002 Application Receipt Date: February 11, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE The National Institute of Environmental Health Sciences (NIEHS) and the National Cancer Institute (NCI) invite applications to create a network of research centers in which multidisciplinary teams of scientists, clinicians, and breast cancer advocates work collaboratively on a unique set of scientific questions that focus on how chemical, physical, biological, and social factors in the environment work together with genetic factors to cause breast cancer. Answering these questions will allow the translation of such findings into information that can be applied to increase awareness of the causes of breast cancer. This program will support a network of cooperative agreements (U01) comprised of research teams, which will work within and across centers on targeted biological and epidemiologic research projects. These projects will be designed to fill specific gaps related to how environmental exposures impact the development of the mammary gland at the cellular, molecular, organ, and population level throughout a woman=s lifetime to influence future breast cancer risk. The research conducted will take a unique developmental approach to integrate time, susceptibility and exposure in order to more fully appreciate the changes that occur in the mammary gland early in life that may predispose the breast to cancer. These projects will help to define specific periods of susceptibility of the breast when environmental stressors may change the molecular architecture of the gland, conferring increased risk of future cancer. The purpose of implementing a network of cooperative breast cancer centers is twofold. The first goal is to integrate scientific information on histologic, pathologic, cellular, and sub-cellular changes that occur in normal mammary gland tissue across the lifespan and compare this to exposure-induced changes. Discovering changes in gene and protein expression due to agents to which young girls and women may be exposed during their lifetime will be a primary goal. Experiments will be conducted cooperatively, using animal models that characterize pathways related to breast and endocrine system development during early life, puberty, pregnancy, and other time points, which may be affected by exposures to environmental stressors occurring at different windows of vulnerability. When clinical specimens are available from women at risk, they will be compared to animal models. Data from these experiments will be made available to the scientific community in order to stimulate further investigations of mechanisms of interest. A second goal is to conduct a focused and coordinated epidemiologic study of determinants of puberty in girls. Attention will be paid to understanding the shift towards earlier puberty among adolescent girls, the identification of environmental exposures in young girls, and the interplay between genetic polymorphisms and environmental exposures that may put them at risk of future breast cancer. The overall goal of this network of centers is to integrate the basic biological, toxicologic, and epidemiologic data on the development and lifespan of the mammary gland in a way that public health messages can be designed to educate young girls and women who are at high risk of breast cancer on the role of specific environmental stressors in breast cancer development and how to reduce exposure to those agents. This information will be useful in developing clinical and public health programs that target breast cancer prevention in young girls and women. This research program complements other programs on breast cancer and mammary gland development being conducted at the National Institutes of Health. The unique focus of this program extends that research by comparing the effects of environmental stressors, including environmental pollutants, nutritional and lifestyle factors, and other exposures on normal mammary gland development in order to more fully consider the multiple causes of breast cancer. RESEARCH OBJECTIVES Background Breast cancer is a complex disease, the causes of which have eluded scientists for many decades. Improvements have been made in early disease detection, surgical and medical modalities for treatment and survival for women with breast cancer. Although scientists and clinicians understand more today about the process of carcinogenesis and genetic susceptibility, effective prevention strategies targeting the causes of breast cancer remain out of reach due to the multiplex of factors involved in breast cancer causation. Historically, research to understand the causes of breast cancer has focused primarily on the role of estrogen. The dose of estrogen to the mammary gland varies over time during a woman=s life and may produce differential risks of cancer. The need to focus on critical windows of vulnerability of the mammary gland, especially the period of time between the onset of menarche and first pregnancy, has been recommended by scientists as central to advancing our knowledge. New technologies are being used to understand the molecular aspects of cell growth and proliferation during this and other critical windows and provide new opportunities to integrate molecular, cellular and organ system level data. Recently, in a series of workshops and meetings conducted by NIEHS, scientists proposed a developmental approach to understanding the initiation of breast cancer, drawing attention to the gaps in our knowledge concerning normal development of the mammary gland, physiology of sexual maturation, and genetic regulation of these processes. A major gap was the lack of data available on environmental factors that may perturb these systems. There is a need to integrate data on the structure and dynamics of cellular and organ system functions from experimental and clinical models of breast development, in order to look at normal physiological pathways and alterations that may occur from environmental stressors. This approach may allow scientists to think about the interplay between environmental, genetic, and physiologic causes of breast cancer in a new way. During the past decade NIEHS has supported research that has focused on understanding the mechanisms of selected environment agents on breast cancer in individuals and in populations. Research programs have focused on understanding the mechanisms of endocrine disrupting chemicals on the female hormonal and reproductive systems, timing of exposures to environmental toxicants and breast cancer risk, and genetic susceptibility to breast cancer. From recent epidemiologic studies it appears that exposures to DDT and polychlorinated biphenyls (PCBs) as measured in adulthood are not related to breast cancer risk in women living in countries where these chemicals are banned. There are some studies suggesting increased risk in women where spraying with DDT continues today. There is evidence that prenatal exposures to dioxin and soy have an effect on mammary gland development. Work has begun to explore the perturbations in molecular mechanisms of mammary gland development in experiments using DDT, PCBs, and polyaromatic hydrocarbons (PAHs) as exposures. The National Toxicology Program rodent bioassay suggests that there are about 40 chemicals that cause breast cancer. Many are industrial exposures and are therefore difficult to study in women. Recent evidence suggests other chemicals such as bisphenol-A, atrazine, certain heterocyclic amines and other polyaromatic hydrocarbons may affect mammary gland development by changing the pattern of branching in the breast affecting primarily the terminal end buds. Scientists are also currently exploring how chemical exposures may change the hormonal milieu and how these changes can impact breast cancer risk. Following on the need to understand what is happening to the mammary gland during critical windows of susceptibility, there is strong evidence that girls less than 14 years old at the time of the atomic bomb in Hiroshima have an increased risk of breast cancer. It has been suggested that early cigarette smoking in adolescence may also increase risk. Recent work in Michigan has shown that girls whose mothers were exposed to polybrominated biphenyls (PBBs) during their pregnancy and after have an earlier onset of menarche. Although evidence exists for selected chemicals, most of the 70,000 chemicals in commerce today remain untested and little data are available on human doses of exposure or cellular or physiologic effects of these exposures on the mammary gland and female reproductive system. During the past decade the NCI has also been actively supporting research on the role of environmental factors on the risk of breast cancer, particularly through epidemiological research and the development of tools such as geographic information systems. Some of these studies have been jointly funded with the NIEHS. NCI-supported research has led to the identification of multiple reproductive factors that are involved in the development of breast cancer. However, there are still significant gaps in the knowledge of changes that occur in normal breast tissue throughout the lifespan and the need for more research on the impact of environmental stressors on breast tissue and pubertal development that may affect breast cancer risk. In addition to studying traditional environmental factors such as chemicals and physical agents, it is necessary to more completely examine the influence of anthropometric and nutritional factors on the mammary gland during development, puberty, pregnancy, lactation and menopause. There have been temporal changes noted in body size, weight, and adiposity in young girls over recent decades that may contribute to earlier age at menarche, precocious puberty, and altered hormonal profiles. These changes in physiological parameters may account for the rise in a woman=s risk of future breast cancer. Social environmental factors, such as poverty, family structure and stress may impact on nutritional choices, physical activity levels, body size and shape, and pubertal development and translate to breast cancer risk factors. There are many gaps in our understanding of how the growth and development of the mammary gland and reproductive system in young girls may be influenced by environmental factors such as changing dietary habits, lifestyle choices, physical activity, and exposures to chemicals in products being used by young girls. This limited evidence will provide a starting point in considering which environmental exposures to consider for more in depth study in both the biological and epidemiologic components of this program. Biological data on cellular and sub-cellular outcomes should be more fully integrated in a way that can facilitate analyses of the interplay between all factors that may cause breast cancer. Such an effort can be useful to examine and differentiate the multi-level interactions that impact the mammary gland and reproductive system as they change over a woman=s lifetime. This information will enhance our appreciation of the biological basis of sexual maturation and allow scientists to test new hypotheses in mechanistic, clinical and epidemiologic studies. A coordinated multi-site study of the environmental and genetic determinants of puberty will translate the basic information on the influence of many factors on the developing breast and reproductive system in young girls to the population level. These two scientific efforts will provide valuable information to the general public on how the total environment of young girls and women impacts the health of the breast. Components of these projects will contribute to our understanding of the heterogeneity of the disease, susceptibility to breast cancer among different groups of women, the development, validation and use of markers of physiologic changes in the breast, and the mechanisms of action of chemicals and other exposures in causing breast cancer. Objectives Each Breast Cancer and the Environment Research Center will be constructed in a way to contribute to the collective effort to provide new information on the normal growth and development of the breast and reproductive systems, provide data at the sub-cellular, cellular, and organ system level in animal models and human populations, evaluating the impact of environmental stressors on the mammary gland, and explore issues related to susceptibility in developing breast cancer. The following five scientific priority areas have been developed after a series of workshops and meetings held on this topic attended by scientists, representatives from breast cancer advocacy groups and health care practitioners. They are: o defining the molecular architecture of the developing and changing mammary gland over the lifespan, o timing of exposure during critical windows of vulnerability, o creation of new and improved animal models and biomarkers to study the impact of environmental stressors on breast cancer, o molecular epidemiology and exposure assessment research focused on studying important gene B environment interactions, o inclusion of community concerns into breast cancer research projects. More information about the workshops held can be found at http://www.niehs.nih.gov/external/bcancer/home.htm. Gaps in our knowledge in each of these important areas will be addressed in the collaborative projects of the Centers. Each Center will contain two collaborative research projects. Collaborative Project 1 is entitled "Environmental Effects on the Molecular Architecture and Function of the Mammary Gland across the Lifespan" and will entail the conduct of collaborative experiments using relevant animal models on the normal development of the mammary gland using a systems biology approach, and effects of selected chemicals and other exposures (i.e. nutritional, social) on endpoints such as breast pathology and gene and protein expression at critical points in time. Collaborative Project 2 will be entitled "Environmental and Genetic Determinants of Puberty" and will be a collaborative multi-site epidemiologic study of sexual maturation in young girls. All study sites will use similar methods to collect data on markers of physiologic changes during the pubertal process, and assessment of environmental stressors of importance to future breast cancer risk, including lifestyle behaviors, nutrition and anthropometric markers, chemical, physical, and social exposures at home and school. In addition, pooled analysis of genetic polymorphisms of interest will be included to fully explore relevant gene–environment interactions. Evidence of active gene pathways from the collaborative project investigating the molecular architecture of the breast will be considered when choosing genetic polymorphisms for study. The study will be designed to increase our understanding of how exposures and physiologic changes occurring during critical windows of breast development may impact on future breast cancer risk. Research Scope The Breast Cancer and the Environment Research Centers Program is intended to create a national network that will foster interaction and collaboration within and between centers. Each center will include the expertise of a diverse array of individuals. Partnerships among scientists, breast cancer advocates, community members, and health care providers will be required. The active participation of the community and national breast cancer advocacy groups and other community or faith based organization will be expected throughout the Center, especially in activities which translate research findings into useful information for the public. Evidence of such participation in activities of the Center and especially those that are involved with translating research findings to the public will be required and reviewed as part of the application package. Collaborations between NIEHS Environmental Health Sciences Centers and NCI-supported Comprehensive Cancer Centers, NCI-supported Breast Cancer Specialized Programs of Research Excellence (SPORE), and Department of Defense Breast Cancer Program-supported investigators are encouraged. Description of a Center The Breast Cancer and the Environment Research Centers should be viewed as formal organizational components within the institution relative to other such existing research components at the institution. Reasonable institutional support should be available to maintain the visibility, credibility and promote interactions with other such units at the host institution. The reporting, accountability, and management structure of the Center within the institution should be equivalent to that of comparable organizations within the institution. Cost sharing when appropriate is encouraged. Administrative Core (approximately four to five percent of budget in years one to seven) Each Center will have two required core activities, an Administrative Core and a Community Outreach and Translation Core. The Principal Investigator of the Center will be the Administrative Core director. This core will serve as the central coordinating body of the Center. Activities that will be directed from the Administrative Core will include: o Coordination of all Center research, meeting attendance, and other activities. o Travel support for Steering Committee, subcommittee, network and scientific meetings. o Support for seminars or other program enhancement activities which support awareness and interest in topics related to breast cancer and the environment. Community Outreach and Translation Core (approximately four to five percent of budget in years one to seven) The function of the Community Outreach and Translation Core (COTC) is to develop and implement strategies to translate the scientific findings of the center into information for the public and policy makers and to determine if they are effective. These activities can include: developing educational materials for children and adults about breast cancer and the environment, conducting environmental justice related activities, conducting public awareness forums, workshops, and meetings with stakeholders to discuss a variety of issues, or to develop and evaluate novel approaches to disseminate research findings to interested parties. COTC activities can also explore areas of concern or interest to the community. For example, ethical issues pertinent to understanding the risks of exposure to environmental pollution, or using new early biomarkers of exposure or breast cancer risk in research. The Center should develop a specific plan and set of integrated activities for COTC, particularly with respect to the Center=s needs to partner with community and target groups. COTC should be a logical outgrowth of the scientific focus of the Center and exhibit the potential for mutual benefit due to interactions with Center research cores and investigators. The COTC may be useful, for example, as a means of establishing a productive relationship with a community-based organization, which could subsequently form the foundation of a successful implementation of the research projects that are part of the Center. The program should not go beyond public and community education about reducing environmental disease risk and/or hazard exposure recognition as the COTC is not intended to give medical, legal, political, social, or economic advice. Collaborative Projects Collaborative Project 1 (CP-1)(approximately 35-45 percent of budget in years one to seven) Collaborative Project 1 is entitled "Environmental Effects on the Molecular Architecture and Function of the Mammary Gland across the Lifespan." The purpose of this project is to conduct collaborative experiments using relevant animal and cell culture models of mammary gland development over the lifespan integrating endpoints such as gene expression, proteomics, and metabonomics, in order to understand the effects of selected chemicals or other environmental exposures on mammary gland pathology in these windows of time. Two main foci guiding this program will include: o exploration of in vitro and in vivo model systems (including cell culture and rodent models) for understanding mammary gland development and changes over the life span including the evaluation of critical windows of sensitivity to environmental agents, o evaluation and selection of potential environmental exposures for further study in appropriate animal or other model systems, via the use of in vitro mechanism-based screens to detect agents that possess signatures indicative of possible mammary gland carcinogenicity. It is anticipated that in the course of this work new and novel biomarkers of altered structure and function will be developed. The development, validation and integration of new and enhanced mechanism-based screening paradigms are also encouraged. The choice and/or methods to characterize endpoints of interest will be left to the applicant but may include breast pathology, gene expression and protein expression profiles of relevant pathways and metabonomic profiles (urine and serum). The goal of this work is to explore scientific hypotheses involved in mammary gland carcinogenesis and toxicologic responses during these windows. Proposals should include the conceptualization of an experimental framework and design for carrying out all aspects of this research. Key hypotheses should be identified as well. The application should include a proposal which defines the experimental approach and methods in the above mentioned two areas, identify and justify choice of appropriate endpoints of interest, time points across the lifespan, animal models and cell culture systems to be used, and data analysis strategies and techniques. Although the final design of the research will be agreed upon by consensus by the Breast Biology Subcommittee of the Steering Committee, it is critical that each applicant address both scientific foci in their application. The Steering Committee will identify common research aims that all Centers will participate in and those aims that may be carried out locally by individual Centers. Overall the key areas of expertise needed to successfully conduct this project in a collaborative manner are: in vitro and in vivo mammary gland biology models, toxicology, pathology, genomics, proteomics, metabonomics and bioinformatics. All expenses to conduct such work, including the use of appropriate facility cores, should be incorporated within the proposal for the collaborative project. It is recognized that all areas of expertise or the capabilities to direct and perform all areas may not be resident at a single institution. Centers may form collaborations or consortium for the purposes of obtaining needed expertise and capacity. Each Center will describe their abilities in each of the areas that are pertinent to their proposal. A description of experience in each area of expertise delineated in the proposal, with publications to support it, should be included in the application. It is not a requirement that any one Center have expertise in all of these areas. After award, decisions will be made by the Steering Committee and the Program Director with regard to which Centers will take responsibility for specific scientific areas. These decisions will be based on expertise and capacity to do the needed work as defined by the Breast Biology Subcommittee. Budget adjustments may be necessary. Collaborative Project 2 (CP-2)(approximately 35-45 percent of budget in years one to seven) Collaborative Project 2 will be entitled "Environmental and Genetic Determinants of Puberty" and will be a collaborative multi-site epidemiologic study of the young girls experiencing physiologic changes of thelarche and sexual maturation and their exposures that can impact on their future risk of breast cancer. All study sites will use standardized methodologies to collect data on markers of breast development and other physiologic changes of sexual maturation, assessment of environmental stressors of importance to future breast cancer risk, including lifestyle behaviors, nutrition and dietary supplements, anthropometry, chemical and physical exposures at home, and school, and social factors. DNA specimens will be collected, stored, and analyzed for relevant polymorphic variation related to pathways of interest in defining susceptibility. Each application should include a detailed study protocol with specific aims to address leading hypotheses (to include but not limited to gene – environment interactions), sample size calculations for individual study sites and combined analyses, definitions for enrolling study subjects and required follow-up time (if a longitudinal design is proposed), methods for collecting exposure data, health outcome data, and biological specimens. Inclusion of novel biomarkers of physiological changes in hormone status, breast development, ovarian and hormonal function, and other measures of skeletal and sexual maturation are encouraged. After awards are made, the Epidemiology Subcommittee of the Steering Committee will integrate all of the meritorious study elements into one cohesive protocol that will be carried out at each Center. Centers should identify areas of expertise and capabilities in areas such as epidemiology, exposure assessment of chemicals and other exposures in biological and environmental media, biostatistics, clinical assessments, clinical laboratory determinations, and genetics, as proposed in their applications. All expenses to conduct such work, including the use of appropriate facility cores, should be incorporated within the proposal for the collaborative project. It is recognized that all areas of expertise or the capabilities to direct and perform all areas may not be resident in each Center. Centers may form collaborations or consortium for the purposes of obtaining needed expertise and capacity. After award, decisions will be made by the Steering Committee and the Program Director with regard to which Centers will take responsibility of specific scientific areas, i.e. chemical exposure assessment, dietary analysis, hormone analysis. A description of such experience in each area of expertise, with publications to support it, should be included in the application. These decisions will be based on expertise and capacity to do the needed work. Budget adjustments may be necessary. Although it is unlikely that any individual study site will have enough power to study in detail relevant gene-environment interactions, applicants are to include and justify such hypotheses to be evaluated for the combined analyses of data. All Centers will maintain a repository of stored biological and environmental specimens for later analysis. Analyses may include analytical chemistry to determine body burdens of chemical exposures. Hormone analysis, and genetic analysis should be incorporated into the proposal study design. The Epidemiology Subcommittee will decide over the course of the study which analyses are necessary. MECHANISM OF SUPPORT This RFA will use the NIH U01 award mechanism. 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 July, 2003. The NIH U01 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIEHS staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." At this time, it is unknown if this RFA will be reissued after the initial program period. FUNDS AVAILABLE The NIEHS and NCI intend to commit approximately up to $5 million dollars up (total costs, including facilities and administrative costs) in Fiscal Year 03 to fund three new grants in response to this RFA. An applicant may request a project period of up to seven years and a budget for direct costs of up to $900,000 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 the cap. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award may also vary. Although the financial plans of the NIEHS and NCI include funds to 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. 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 institutions. Applications will not be accepted from foreign institutions, however, foreign institutions may establish sub-contract arrangements with domestic applicant institutions. Partnerships between researchers and members of community based organizations, faith based organizations and grass roots advocacy organizations that are concerned with breast cancer are required. Applications that do not include such partnerships will be returned as non-responsive. 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 his or her institution to develop an application for support. Individuals from under represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Awards made under this program must be interdisciplinary efforts bringing together investigators from different scientific disciplines. In order to be funded, each applicant must successfully meet the requirements as stated below: o Center Director should be a well-recognized scientist in the field of mammary gland biology or environmental health sciences. The Center Director is expected to work to provide stewardship and balance to the overall program as it develops, conducts and reports on research conducted under the Center umbrella. o It is expected that a wide variety of disciplines will be represented in the expertise of the Center. Applicants should include expertise in mammary gland biology and carcinogenesis, environmental health sciences and toxicology, molecular biology, epidemiology, exposure assessment, biostatistics, and community based participatory research. Clinical expertise is also encouraged as part of the Center. o Proposals for two collaborative projects. o Investigators who are named as part of the two collaborative projects will be expected to work together with the other centers on the research. This will entail participating in multiple planning and implementation meetings of each collaborative project during the first year. Methods and approaches will be decided upon by consensus. Less frequent meetings are envisioned after the collaborative projects are launched, but there will be a minimum of two such meetings a year for each collaborative project committee in years two to seven. o Each year the Centers will be involved in planning one scientific workshop/conference on emerging issues in breast cancer and the environment. The location of such a meeting and primary logistical support for the meeting will rotate across the centers. A planning committee with scientific and community members from each center will be formed each year and will be charged with carrying out this task. NIEHS and NCI program staff will provide assistance to this effort. Cooperative Agreement Terms and Conditions of Award The following terms and conditions will be incorporated into the U01 award statement, and will be provided to the Center Director and the awardee institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. [Part 92 applies when state and local governments are eligible to apply as a "domestic organization."] The administrative and funding instrument used for the applicants to this program is a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardee and NIEHS and NCI through the Steering Committee. 1. Definitions NETWORK: The Centers supported as a result of this RFA will form the basis of the network of Breast Cancer and the Environment Research Centers Program. These Centers will work collaboratively on two projects; "Defining the Effects of Environmental Exposures on the Molecular Architecture of the Mammary Gland over the Lifespan," and "Environmental and Genetic Determinants of Puberty." The network will work collaboratively on holding an annual meeting on emerging topics in breast cancer and the environment. NATIONAL ADVISORY BOARD: A subcommittee of the National Advisory Environmental Health Sciences Council (NAEHSC) will be established, with ad hoc members as appropriate, to provide advice to the Director, NIEHS, related to this program. Subcommittee members who are standing members of the NAEHSC will also have responsibility for the second level review of all applications for this program. The subcommittee will provide advice on the topics to be considered at the annual workshop/conference in emerging areas in breast cancer and the environment. This subcommittee will meet with the Steering Committee once a year to review progress and make recommendations about future directions for the program. BREAST CANCER and the ENVIRONMENT TASK FORCE: A group of federal program directors or scientists that can provide oversight and advice about the progress of the collaborative research projects. These government scientists may also provide liaison to other federally supported resources, such as tissue repositories, animal model consortiums, or genomics databases. This task force will meet with the grantees and may review materials and products of the research as needed to provide input. 2. Awardee Rights and Responsibilities o The Center Director will coordinate project activities scientifically and administratively at the awardee institution and at the other sites that may be supported by sub-contracts to this award. The Center Director of a U01 grant will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award. o The Center Director will assume responsibility and accountability to the applicant organization officials and to the NIEHS and NCI for the performance and proper conduct of the research supported by the U01 in accordance with the terms and conditions of the award. o The Center Director, and a member of the Community Outreach and Translation Core who represents the views and concerns of the breast cancer advocacy community, will serve, as voting members of the Steering Committee, and will attend the Steering Committee meetings and appropriate subcommittee meetings. o The Center Director will be responsible for accepting and implementing the goals, priorities, procedures, and policies agreed upon by the Steering Committee. o The Center Director of a U01 will be responsible for close coordination and cooperation with the other components of the Network, the Steering Committee, and with the NIEHS and NCI staff. o The Center Director will submit periodic progress reports in a standard format, as determined by the NIEHS and NCI. o Awardees will retain custody of, and have primary rights to, the data developed under these awards at their institution, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. They will also share these data with other Centers as needed. The policy of the PHS is to make available to the public the results and accomplishments of the activities that it funds. The Center Director agrees to data sharing and data pooling practices as designed by the Steering Committee and subcommittees. o The Center Director is responsible for effective communication and collaboration with the Network. There will be sharing of data and other information among the Centers and between the Centers and the NIEHS and NCI. Awardees are responsible for developing or enhancing their Internet communication tools to ensure effective communication among the different components that form the U01 grant (such as, sub-contracts, individual core facilities at the institution), the other Centers, and with NIEHS and NCI. 3. Extramural Staff Responsibilities o The NIEHS and NCI Program Directors will provide normal stewardship for the U01 awards under this RFA. The NIEHS and NCI Program Directors will review the scientific progress of individual U01s, and review them for compliance with the operating policies developed by the Steering Committee. The NIEHS and NCI Program Directors may recommend withholding support, re-allocating support among awardees, and suspension or termination of a U01 award for lack of scientific progress or failure to adhere to policies established by the Steering Committee. o The NIEHS and NCI Coordinators will have substantial scientific and programmatic involvement to assist, guide, coordinate, and participate in the conduct of the Network activities. The NIEHS and NCI Coordinators will coordinate and facilitate the Network activities, will attend and participate in all meetings of the Steering Committee and subcommittees, and will provide liaison between the Steering Committee, the Network and the NIEHS/NCI/NIH and other federal agencies as needed. The NIEHS and NCI Coordinators along with supporting staff will work with the Network to facilitate one conference/workshop per year on emerging topics in breast cancer and the environment. o The NIEHS and NCI Coordinators will coordinate meetings and activities that involve the network of Centers, the Steering Committee, and the National Advisory Environmental Health Sciences Council subcommittee on breast cancer and the environment. The NIEHS and NCI Coordinators will regularly consult with the Breast Cancer and the Environment Task Force on the scientific progress of the Network. Task force members will have access to progress reports and other relevant information submitted by the U01 awardees. o The NIEHS and NCI Coordinators will assist the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require a coordinated action. o Federal government staff with relevant scientific expertise or who manage research grant programs that relate scientifically to the goals of the network will form the Breast Cancer and the Environment Task Force. The Task Force will meet regularly to review the progress of the Network and to recommend to the NIEHS and NCI Program Directors scientific developments and opportunities that may enhance the achievement of the network goals. o The NIEHS and NCI Program Directors may also function as the NIEHS and NCI Coordinators for this program. 4. Collaborative Responsibilities Upon acceptance of an award, investigators agree to participate in the cooperative nature of the Network and to work collaboratively on two research projects. Investigators agree to exchange information freely within the Network and publish in the scientific literature according to procedures that the Steering Committee puts into place. Investigators agree to participate in all meetings necessary to further the collaborative goals of the program. 5. Steering Committee o An arbitration system, as detailed below, will be available to resolve disagreements between the NIEHS and NCI Program Directors and the members of the Steering Committee. o The Steering Committee will be the main governing board of the Network. It will function to set priorities for Centers program and its collaborative projects. o The Steering Committee will be composed of the director and a member of the Community Outreach and Translation Core who represents the views and concerns of the breast cancer advocacy community from each U01. The two representatives from each U01 will each have one Steering Committee vote. The chairperson, who will be someone other than an NIEHS/NCI/NIH staff member, will be selected by the Steering Committee. The NIEHS and NCI Program Directors are non-voting members of the Steering Committee, and will facilitate creation of the group and will attend all meetings. NIH staff may not serve as the Committee chair. o The Steering Committee may, when it deems it to be necessary, invite additional, non-voting scientific advisors to the meetings at which research priorities and opportunities are discussed. The NIEHS and NCI reserves the right to augment the scientific or consumer expertise of the Network when necessary. o There will be one Steering Committee meeting annually. The initial planning meeting will be organized by NIEHS and NCI, but subsequent meetings will be organized by the Steering Committee. The committee=s chair will schedule the meetings and will be responsible for meeting agendas (in collaboration with the Program Director), chairing the meetings, and producing Steering Committee=s reports. The same procedure will take place for the two subcommittees of the Steering Committee. Chairs will be selected and responsibilities with regard to agenda planning, chairing the meetings, and producing reports will follow the model of the Steering Committee. o There will be two subcommittees of the Steering Committee, the Breast Biology Subcommittee and the Epidemiology Subcommittee. Each subcommittee will plan and implement the collaborative projects. The Breast Biology Subcommittee will be comprised of the necessary senior investigators from CP-1 in each center, and the Epidemiology Subcommittee will be comprised of the necessary senior investigators from CP-2 in each center. Each Center will designate one member of the Community Outreach and Translation Core who can represent the views and the concerns of the breast cancer advocacy community to participate in each subcommittee. Each subcommittee will designate a chair, who, in addition to directing the activities of the subcommittee, will keep the NIEHS program director and Steering Committee apprised of progress of their respective collaborative project. Each subcommittee will meet as needed by conference call, videoconference or in person and will report to the Steering Committee annually. It is estimated that each subcommittee will each meet face-to-face up to four times in the first year of each collaborative project. The initial planning meeting will take place in the Research Triangle Park, NC, with subsequent meetings at a location that the Steering Committee/subcommittees select and with which the NIEHS and NCI concur. The NIEHS and NCI Program Directors or their designee(s) will attend all subcommittee meetings. NIH representation on the Steering Committee will never make up a majority of the total number. o The first meeting of the Network will be a Planning Meeting, which will take place in the Research Triangle Park, NC, very shortly after the awards are finalized. At the Planning Meeting, the Steering Committee and subcommittees will be formed and select chairpersons from among the members who represent the U01 awardees. Steering Committee will also draft and agree to: the terms of a charter to detail policies and procedures, a process for monitoring compliance with the policies and procedures, and a process for recommending that the NIEHS and NCI Program Directors act on evidence of non-compliance of any Consortium component with Steering Committee policies. o The Steering Committee will work collaboratively to hold one workshop/conference a year, to which non-Network participants and the general public may be invited to enable the Network to explore scientific or technological innovations that occurs during the course of the project. These meetings will also serve to inform the research and interested public of the progress of the Centers. The organization of the workshops and symposia will be the responsibility of the Network members. NIEHS and NCI may choose to provide supplemental funds to the selected host institution, after the receipt of an appropriate application and review by the Steering Committee. o The Steering Committee may establish additional subcommittees. The NIEHS and NCI Program Directors and the other NIEHS/NCI/NIH staff may serve on subcommittees, as they deem appropriate. 5. Arbitration Process Any disagreement that may arise on scientific/programmatic matters (within the scope of the U01 award), between U01 awardees and the NIEHS and NCI may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Steering Committee (without NIH representatives voting), or by the individual U01 awardee in the event of an individual disagreement; a second member selected by the NIEHS and NCI; and, the third member selected by the two prior selected members. For U01 awardees, this special arbitration procedure in no way affects the awardees' right to appeal an adverse action that can otherwise be appealed in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. 6. Yearly Milestones and Evaluations Awardees will finalize yearly milestones at the time of their awards. The awardees= milestones will be provided to the Steering Committee. It is expected that the milestones will be adjusted annually at the award anniversary dates, both to incorporate a group=s scientific accomplishments and progress in the field in general, as well as to reflect the recommendations of the Steering Committee. In accord with the procedures described above, NIH may withhold or reduce funds for projects that substantially fail to meet their milestones or to maintain their research activities as state-of-the-art. 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: Gwen W. Collman, Ph.D. Scientific Program Administrator 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) 541-4980 Fax: (919) 316-4606 Email: firstname.lastname@example.org Kumiko Iwamoto, M.D., Dr.P.H. Epidemiology and Genetics Research Program National Cancer Institute 6130 Executive Boulevard, Room 5115 Bethesda, MD 20892-7324 Telephone: (301) 435-4911 Fax: (301) 402-4279 Email: email@example.com o Direct your questions about peer review issues to: Sally Eckert-Tilotta, Ph.D. Scientific Review Administrator Scientific Review Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-30 Research Triangle Park, NC 27709 Telephone: (919) 541-4446 Fax: (919) 541-2503 E-mail: firstname.lastname@example.org o Direct your questions about financial or grants management matters to: Ms. Lerlita Garcia Grants Management Specialist Grants Management Branch National Institute of Environmental Health Sciences P. O. Box 12233, MD EC-22 Research Triangle Park, NC 27709 Telephone: (919) 316-4638 Fax: (919) 541-2860 Email: email@example.com Ms. Crystal Wolfrey Team Leader, DCCPS Team Grants Administration Branch National Cancer Institute 6120 Executive Blvd, Suite 243 Bethesda, MD 20892 (for regular mail) Rockville, MD 20852 (for hand-delivered mail) Telephone: (301) 496-8634 Fax: (301) 496-8601 Email: firstname.lastname@example.org 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 in each collaborative project and cores o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIEHS staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Sally Eckert-Tilotta, Ph.D. Scientific Review Administrator Scientific Review Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P. O. Box 12233, MD EC-30 Research Triangle Park, NC 27709 Telephone: (919) 541-4446 Fax: (919) 541-2503 E-mail: email@example.com Courier Service Address: Building 4401, Room 3171 79 TW Alexander Drive Research Triangle Park, NC 27709 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001.) The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive form. For further assistance contact Grants Info, telephone (301) 435-0714, Email: GrantsInfo@nih.gov SUPPLEMENTAL INSTRUCTIONS The body of the scientific application will be composed of the following sections with the appropriate page limitations: - Introduction and organization of Center B 5 pages maximum - Administrative Core - 15 pages maximum - Community Outreach and Translation Core - 20 pages maximum - Collaborative Project 1 - 25 pages maximum - Collaborative Project 2 - 25 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 the Cores and Collaborative Projects 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, "Breast Cancer and the Environment Research Centers," and number, RFA ES-03-001, 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 available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf SENDING AN APPLICATION TO THE NIH Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Sally Eckert-Tilotta, Ph.D. Scientific Review Administrator Scientific Review Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-30 Research Triangle Park, NC 27709 Telephone: (919) 541-4446 Fax: (919) 541-2503 E-mail: firstname.lastname@example.org Courier Service Address: Building 4401, Room 3171 79 TW Alexander Drive Research Triangle Park, NC 27709 APPLICATION PROCESSING Applications must be received by the application receipt date listing 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 NCI. 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 National Cancer Advisory 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. 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: - Significance - Approach - Innovation - Investigator - Environment The scientific review group will address and consider each of these criteria in assigning your application=s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. OTHER REVIEW CRITERIA A. Overall Center Centers must include proposals for collaborative research projects with a conceptual theme focusing on breast cancer and the environment as outlined in the RFA. There must be evidence of the potential for a meaningful interdisciplinary collaboration between a multiple areas of science and community based advocacy groups which are concerned with breast cancer. 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 plans for active participation of breast cancer advocacy groups and other relevant community groups in the conceptualization, planning, implementation, and handling and dissemination of research and findings whenever appropriate. o Evaluate how Center scientists propose to work collaboratively within the Center, across centers as needed for the completion of the two collaborative projects, and across Centers to enhance research opportunities being explored in investigator initiated activities. B. Collaborative Projects Environmental Effects on the Molecular Architecture of the Breast Across the Lifespan o Judge the innovation and appropriateness of the scientific hypotheses, research approaches and methodology proposed to make a significant contribution to the field of study. o Evaluate the ability of the applicant group to contribute sufficiently to the collaborative efforts in the each of the needed areas of expertise (ie. animal models/pathology, genomics, proteomics, bioinformatics.) Strengths and weaknesses in areas will be described. o Evaluate the resources available at the institution (instrumentation, space, capacity) to handle the work load of the collaborative project as designed by the applicant. o Evaluate the abilities of the investigators to contribute meaningfully to the development and conduct of collaborative activities. Environmental and Genetic Determinants of Puberty o Judge the innovation and appropriateness of the scientific hypotheses and research methods proposed to make a significant contribution to the field of study. o Evaluate the ability of applicant group to contribute sufficiently to the collaborative efforts by demonstrating the capacity to recruit and follow-up needed study subjects, design and employ appropriate exposure assessment methodologies for all potential risk factors, and collection, banking and analysis of biologic specimens. o Evaluate the contribution of biostatistical expertise available to the goals of the collaborative project. o Evaluate the contribution of expertise in molecular epidemiology to contribute to the collaborative efforts of studying gene-environment interactions as part of this study. 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. D. Community Outreach and Translation Core (COTC) o Evaluate the appropriateness of the proposed core activities with regard to the potential for engaging community support for Center research projects, adequate dissemination of study findings, and translation of research findings to public health action. o Evaluate the expertise of core members to fulfill the mission of the COTC. E. Institutional Commitment o Evaluate the effectiveness of the Center as a formal organizational component within the institution relative to other organizational components. o Determine whether the reporting, accountability, and management structure of the Center within the institution are equivalent to that of comparable organizations within the institution. Assess the adequacy of institutional procedures and plans for monitoring, evaluating, and assuming accountability for the general success of the Center. 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. ADDITIONAL REVIEW CRITERIA In addition to the above criteria, your application will also be reviewed with respect to the following: 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. Inclusion: The adequacy of plans to include subjects from 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) Data Sharing: The adequacy of the proposed plan to share data. Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 31, 2002 Application Receipt Date: February 11, 2003 Peer Review Date: April, 2003 Council Review: May, 2003 Earliest Anticipated Start Date: July, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review). o Availability of funds. o Programmatic priorities. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines@ on the Inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html 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 on Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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, "Breast Cancer and the Environment Research Centers" 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, 93.114, and 93.115, and is not subject tot he intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Pubic Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm 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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