GEOGRAPHIC-BASED RESEARCH IN CANCER CONTROL AND EPIDEMIOLOGY Release Date: July 11, 2000 PA NUMBER: PAS-00-120 National Cancer Institute Letter of Intent Date: October 9, 2000 and June 14, 2001 Application Receipt Date: November 13, 2000 and July 19, 2001 THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The recently published Atlas of Cancer Mortality in the United States, 1950- 1994(*1) displays the geographic patterns for various forms of cancer (see This PA encourages applicants to use this exciting new resource as a catalyst for research in cancer etiology and control. Further epidemiologic research is needed to identify the reasons for the geographic variation of specific cancers including the clustering of areas with high or low incidence and/or mortality rates. In addition, Geographic Information Systems (GIS) provide new tools for the exploration of such geographic patterns. GIS can be used for assessment of environmental risk factors, identification of places and/or subpopulations where cancer surveillance and control programs are needed, statistical analysis of spatial patterns and presentation, and dissemination of information to the public. The NCI wishes to stimulate research in three areas in order to encourage researchers to use the Atlas to speed the process of scientific discovery and application. The areas include: (1) epidemiologic research to study the determinants of the geographic patterns uncovered by the Atlas, (2) use of GIS for cancer research in response to the Atlas, and (3) methodologic GIS research needed to accomplish such research. This PA is for investigator-initiated R01 applications. A PA for smaller R03 applications is being advertised in parallel to this announcement ( This PA will expire on July 20, 2001. RESEARCH OBJECTIVES This PA will facilitate interdisciplinary collaborations among researchers to foster appropriate use of the recently published Atlas of Cancer Mortality in the United States, 1950-1994 to examine geographic variations in cancer and to study the factors that may contribute to the variations. It also will facilitate integration of new GIS tools for epidemiologic and behavioral research, cancer surveillance and control research, promote development of GIS methodology, and encourage researchers to integrate different types and geographic levels of data in epidemiologic research and in planning, implementation and evaluation of cancer-related programs. The proposed mechanism is a Program Announcement, with a set-aside, to encourage NIH grant-funded research in these three areas. It is a response to the recently released Atlas, to technological advances in science and to advisory group recommendations. Specifically, this PA responds to a recommendation of the Surveillance Implementation Group (SIG) Report (March 1999) that the DCCPS Surveillance Research Program explore the feasibility and utility of employing GISs for geocoding surveillance data and reporting geographic relationships among screening measures, risk factors (including environmental exposures), and improved cancer outcomes , as well as increasing general interest in the use of GIS by public health researchers. 1. Background The new Atlas of Cancer Mortality in the United States shows the geographic patterns of cancer death rates in over 3,000 counties across the country for more than four decades. The Atlas uses 1950-94 mortality data from the National Center for Health Statistics and population estimates from the Census Bureau. Rates per 100,000 person-years, directly standardized using the 1970 U.S. population, are calculated by race (whites, blacks) and sex for 40 forms of cancer. The Atlas includes more than 250 computerized color- coded maps showing variations in cancer rates during 1970-94 and compares them with corresponding maps for 1950-69. Summary tables and figures are also presented. Maps, tables, and the underlying data from the new Atlas are also available on the Web at Another feature of the atlas Web site is that the user can create customized maps to look at cancer rates in any county. The updated maps show that previously observed patterns of selected cancers have persisted. For some tumors, the geographic clustering of areas with elevated rates has become more pronounced in the recent time period. Follow- up studies of geographic relations among cancer mortality rates demonstrated in the first published cancer atlas have led to such notable findings as the association of snuff dipping and oral cancer(*2) and the association of shipyard asbestos exposure and lung cancer(*3). The updated geographic patterns will provide direction in formulating etiologic and other hypotheses, and in targeting high-risk populations for further epidemiologic research and cancer control interventions. One new method which allows the evaluation of the spatial distribution of disease and disease risk is Geographic Information System (GIS). A GIS is a computer system which carries out various data management and analytic tasks on spatially referenced data. The basic elements of a GIS are geographic data and a computer system for input, storage, processing, linkage, analysis, modeling, and display (for more information, see A GIS produces a series of stacked maps or data layers of georeferenced data linked to descriptive attribute information. By processing multidimensional data at different geographic levels and maintaining the spatial relationships among them, a GIS provides a powerful tool for the analysis and presentation of spatial data. In addition, a GIS is capable of integrating both spatial and temporal data. This is important when studying diseases such as cancer for which the relevant time period of exposure may have occurred many years prior to diagnosis. The National Cancer Institute (NCI) has supported a variety of modest efforts in this area through intramural research and extramural contracts and has recently funded a large GIS project for breast cancer research on Long Island. A GIS is a unique tool for the analysis of the spatial structure of data, because it has the capability to analyze associations among data collected at virtually any geographic resolution. Ecologic analyses can be conducted at a finer geographic resolution than previously possible. Therefore, researchers may use GIS to develop hypotheses about cancer etiology and control. In the past, important links between cancer mortality and risk factors have been identified by astute observers who brought personal knowledge of local areas to bear on cancer mortality maps. Now, a GIS can present layers of risk factor data, providing a more systematic and efficient way to explore these associations. The layering of information, such as water source, land use, location of pollution sources and cancer screening facilities, and various other environmental, demographic and lifestyle information, also offers advantages in exposure assessment for both ecologic and analytic epidemiologic studies. For individual-based exposure assessment, researchers can analyze spatial and spatio-temporal relationships (e.g., proximity of a study participant to a pollution source). More importantly, researchers can incorporate information about the geophysical environment into the GIS, e.g., to ascertain the transport of a pollution source or to identify physical barriers, such as distance, to screening facility utilization. Applications of GIS in cancer research include both exploratory and confirmatory spatial analysis of cancer incidence, mortality, survival, and/or prevalence in local populations. Investigators can use a GIS to monitor cancer patterns and their changes over both time and space, thus serving as a tool for surveillance, planning and evaluation of cancer control strategies as well as for implementation of culturally relevant cancer prevention and intervention efforts in economically disadvantaged and underserved communities. Investigators can develop hypotheses about the relationships between cancer rates and community characteristics for the purpose of focusing future etiologic studies and determining community barriers to cancer screening and prevention programs. The latter type of study will help target further research to analyze social factors, such as socioeconomic status (SES), education, coping resources and support systems, residential factors, cultural variables, institutional and political forces such as racism and classism, familial factors, health access and health outcomes and media influences. In etiologic studies, a GIS can aid in evaluating patterns of community and individual characteristics such as occupation, ethnicity and lifestyle factors that may be related to the cancer rates in the area. A GIS is also a valuable tool for the evaluation of environmental exposures which cannot be obtained by questionnaires or direct measurements. GIS-based environmental exposure assessment will be useful in understanding cancers with shorter latencies, e.g., childhood leukemias, however, cancers with longer latencies can be studied when data are available. A GIS has proven to be a valuable tool for the modeling of the fate and transport of environmental contaminants. Examples of models that lend themselves well to GIS-based technology include models of air pollutants, ground water quality, and pesticide transport. Substantial methodologic advances are needed before GIS can reach its full potential in cancer research. For example, once a GIS database is compiled, how may these data be used by researchers to identify areas with unusually high rates and to examine the links between potential causal factors and these geographic patterns. Issues of data availability, quality, and confidentiality must be addressed, analytic methods must be enhanced, and presentation methods improved. Risk factor, confounding factor and disease data must be collected, measured and georeferenced in a standardized way for all small areas and, where possible, for all minority and underserved groups in the study region. Once researchers identify suitable georeferenced data, they need analytic methods to evaluate the spatial and spatio-temporal patterns of cancer incidence, survival and death and the associations of these patterns with those of relevant exposures. Current methods for exploratory data analysis are limited to smoothing techniques with often untenable assumptions, e.g., kriging, or pairwise comparisons of disease and exposure maps. We must also encourage the formal development of formal methods for evaluating the magnitude of effects and mechanisms through which health may be influenced by sociocultural factors. More advanced methods of visualizing multivariable associations among geo-referenced data are needed. For confirmatory analysis, statistical methods for the assessment of spatial or spatio-temporal patterns of cancer and their association with potential risk factors need to be expanded beyond current methods. Automated identification of statistically meaningful cancer clusters is needed to objectively evaluate apparent "hot spots" on cancer maps so as to better focus etiologic and intervention studies and to allay fears of cancer in communities where occasionally high cancer rates are likely due to chance variation over time. Summary The recently published Atlas of Cancer Mortality in the United States, 1950- 1994 displays the geographic patterns for various forms of cancer. This PA encourages applicants to use this exciting new resource as a catalyst for research in cancer etiology and control. Further epidemiologic research is needed to identify the reasons for the geographic variation of specific cancers including the clustering of areas with high or low incidence and/or mortality rates. In addition, Geographic Information Systems (GIS) provide new tools for the exploration of such geographic patterns. GIS can be used for assessment of environmental risk factors, identification of places and/or subpopulations where cancer surveillance and control programs are needed, statistical analysis of spatial patterns and presentation, and dissemination of information to the public. The NCI wishes to stimulate research in three areas in order to encourage researchers to use the Atlas to speed the process of scientific discovery and application. The areas include: (1) epidemiologic research to study the determinants of the geographic patterns uncovered by the Atlas, (2) use of GIS for cancer research in response to the Atlas, and (3) methodologic GIS research needed to accomplish such research. Examples of Studies Sought Applications in Epidemiologic Research o Analytic epidemiologic studies, (e.g., case-control or cohort studies) to identify risk factors such as occupation, lifestyle factors, environmental contaminants for cancers showing interesting geographic and/or temporal patterns and cancers, including but not limited to those for which GIS-based analyses might be particularly useful. Small studies may complement ongoing or existing studies. o Ecologic studies of cancer patterns: generate hypotheses about etiologic and prognostic factors responsible for geographic patterns of cancer and/or changing patterns over time. o Development of a GIS for specific ecologic or analytic epidemiologic studies o Development of a GIS for exposure assessment to use in future, ongoing, or existing epidemiologic studies. Applications in Cancer Control o Cancer and cancer control surveillance: monitor emerging trends in cancer- related health behaviors, incidence, mortality, or treatment in a particular area. o Sociocultural studies: Identify under-served or high-risk sub-populations by examining the inter-relation of ethnicity, access to and use of health services, SES, health behaviors and other cancer risk factors through the use of GIS and/or the Cancer Atlas. o Sociocultural studies: Improve methodologies for examining the juxtaposition of culture and behavior in spatial terms by assessing the influence of spatial relationships with cancer-related behaviors, e.g., examine spatial relationship of neighborhood crime, physical activity, intake of fruits and vegetables and travel distance to purchase produce, examine issues regarding barriers to health care by exploring the concept of distance e.g. what do people consider a long way to go to the doctor? too many buses? travel through unknown or dangerous neighborhoods?, etc., explore the disproportionate placement of hazardous waste sites in low-income and minority communities. o Neighborhood and community research: Combine GIS analyses with quantitative epidemiological analyses and survey methods to examine the relationship of neighborhood conditions (e.g. poverty, environmental pollution) to cancer-related behaviors and practices and/or indicators of disparities in health outcomes. Measure relationship between cancer-related behaviors of families/communities and neighborhood structural factors such as impoverishment, geographic isolation, residential instability, economic resources. o Communication of cancer risk and/or rate information to the public using the Atlas and/or GIS. Methods development o Improve and/or develop methods related to geographic-based data, e.g., protecting data confidentiality, identifying specific locations of cancer cases and exposure sources, geocoding, standardized methods for collecting detailed data, i.e., occurrence, timing and sequencing of life events or demographic processes. o Develop and validate GIS-based databases relevant to studies of cancer epidemiology and control, e.g., environmental databases for exposure assessment, model-based exposure estimates. o Refine analytical methods for geographic and/or GIS-based cancer research, e.g., statistical assessment of spatial or spatio-temporal cancer patterns or a change in these trends, analysis of multivariate cancer and risk factor data, automated identification of cancer clusters, small-area estimation of cancer-related factors from larger-area survey data, methods for integrating environmental models into epidemiologic studies. o Examine issues related to the visualization and presentation of GIS data, e.g., how to use-new technologies to improve the design of GIS maps and usability of computer-user-interfaces, studies of GIS design and usability, appropriate methods of conveying cancer risk information to the public through a GIS. o Develop extensions or software links to existing GIS software to add analytic tools such as described above. MECHANISM OF SUPPORT This PA will use the National Institute of Health (NIH) research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. NIH Grants policies apply to these awards. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at FUNDS AVAILABLE The NCI has budgeted $3 million total costs (direct plus facilities and administrative costs) for the first year of funding for each round of applications received, subject to the availability of funds. This amount includes those grants selected for funding for this PA as well as the parallel PA for R03 submissions ( It is expected that NCI will make a total of four to seven R01 awards for periods up to five years. The number of awards and individual level of support are dependent on the receipt of a sufficient number and diversity of applications with high scientific merit. Program balance and diversity of topics will be factors in selecting applications for award. Budget requests should be justified and commensurate with the needs of the project. Annual budgets for years two through four should not exceed the first year budget plus a 3% yearly increase. Equipment needs, especially in future years, must be well justified. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and not- for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. The total requested project period for an application submitted in response to this PA may not exceed five years. Foreign applications will receive no support for Facility and Administrative (F&A) costs. Domestic applications may include international components but these components will receive no support for F&A costs. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Burdette (Bud) W. Erickson, Jr., M.Sc. Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Blvd., Rm. 240H Bethesda, MD 20892 Telephone: (301) 435-4913 FAX: (301) 402-4279 Email: Direct inquiries regarding fiscal matters to: Ms. Sara Stone Grants Administration Branch National Cancer Institute 6120 Executive Blvd., Rm. 243 Bethesda, MD 20892 Telephone: (301) 496-9927 FAX: (301) 496-8601 Email: LETTER OF INTENT Prospective applicants are asked to submit, by the date listed at the beginning of this PA, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the PA in response 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 a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent to Mr. Burdette W. Erickson, Jr., listed under INQUIRIES by the letter of intent receipt date listed in the heading of this PA. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted on or before the receipt dates indicated on the first page of this announcement. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892- 7910, telephone 301/435-0714, E-mail: The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. For those applicants with internet access, the 398 kit may be found at Applicants planning to submit an application requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute program staff before submitting the application, i.e. as plans for the study are being developed. Furthermore, the applicant must obtain agreement from the Institute staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page (see for sample pages). At the top of the page, enter the total direct costs requested for each year. This is not a form page. o Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is domestic or foreign. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to this PA and will be returned without further review. Submit a signed, typewritten original of the application, including the checklist, and five signed, exact, single-sided photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express service) Applications must be received by the receipt date on the front page of this PA. 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 PA 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR). Incomplete applications will be returned to the applicant without further consideration. Applications that are complete will be evaluated for scientific and technical merit by a special peer review group convened by CSR in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders and minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994 available on the web at the following URL address: INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH 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 clear and compelling 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site (see 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 PA, Geographic- based Research in Cancer Control And Epidemiology , is related to the priority area of Cancer. Potential applicants may obtain a copy of "Healthy People 2010" or at AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Research. Awards are made under authorization of the Sections 301 and 405 of the Public Health Service Act as amended ( 42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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. 1. Devesa SS, Grauman DJ, Blot WJ, Pennello GA, Hoover RN, Fraumeni JF Jr. Atlas of Cancer Mortality in the United States, 1950-94. NIH Publ. No. 99- 4564. Bethesda, MD: National Institutes of Health, 1999. See accompanying web site: 2.Winn DM, Blot WJ, Shy CM, Pickle LW, Toledo A, Fraumeni JF Jr. Snuff dipping and oral cancer among women in the southern United States. N Eng J Med 304:745-9, 1981. 3. Blot WJ, Morris LE, Stroube R, Tagnon I, Fraumeni JF Jr. Lung and laryngeal cancers in relation to shipyard employment in coastal Virginia. J Natl Cancer Inst 65:571-5, 1980.

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