EXPOSURE ASSESSMENT METHODS FOR CANCER RESEARCH Release Date: December 20, 2000 RFA: CA-01-018 National Cancer Institute National Institute of Environmental Health Sciences Letter of Intent Receipt Date: February 19, 2001 Application Receipt Date: April 19, 2001 THIS RFA 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 RFA. PURPOSE The Division of Cancer Control and Population Sciences of the National Cancer Institute (NCI) and the Division of Extramural Training and Research of the National Institute of Environmental Health Sciences (NIEHS) invite exploratory/developmental R21 grant applications from investigators to develop, improve, and/or validate environmental exposure assessment methods applicable in epidemiologic research on cancer. Of special interest will be methods and markers that can be potentially useful in studies of environmental epidemiology focusing on tumor initiation (etiology) and exogenous environmental factors, other than infectious agents. Consideration of bio- behavioral and psychosocial measurements as secondary or confounding factors associated with environmental exposures and cancer risk may be included. The exploratory/developmental (R21) grant mechanism is used for pilot projects or feasibility studies to support creative, novel, high risk/high payoff research that may produce innovative advances in science. Historically, mechanisms designed to stimulate and fund basic bio-behavioral research have not existed as they have for basic biomedical research. Thus, it has been difficult for scientists to obtain funding for these activities through the traditional investigator-initiated research project grant (R01) mechanism. This RFA encourages applicants to, for example, gather data to determine the practicability of a method or approach; to explore the validity of various approaches, including statistical modeling, prior to their incorporation in an epidemiologic study; and to characterize factors that may limit quantitation of environmental exposures relevant to cancer risk. Studies are not to be used to provide preliminary research data for research grant applications but may confirm or extend previous preliminary results that can be of significant usefulness in establishing exposure assessment protocols and evaluations. Proposed research duplicating that which is currently supported should not be submitted. RESEARCH OBJECTIVES Background Recent scientific and biotechnological advances, particularly in molecular biology and genetics, have provided new insights and research directions into the pathogenesis of cancer. Identification of candidate genes, such as BRCA1 and BRCA2 in breast/ovarian cancer and the familial adenomatous polyposis (FAP) gene in colon cancer, has led to a better understanding of cancer susceptibility and risk for a small percentage of the general population. However, for many malignancies, why some individuals subsequently develop cancer while others do not remains an enigma. It has been estimated that environmental factors contribute to 75-80% of all cancers, which are, thus, considered potentially avoidable (1). Whether the effects of environmental exposures may be multiple or may vary according to cancer type, e.g., as cancer risk factors, modifiers of gene expression in carcinogenesis, or as variables interacting with other factors, such as genetic and behavioral, are research questions of widespread scientific interest. Characterization of environmental determinants of cancer continues to be an important goal for developing effective public health strategies in prevention and control of cancer. Informative epidemiologic investigations of environment-cancer relationships, including cancer risk, rely on accurate, quantifiable exposure measurements. To date, traditional research instruments estimate exposure to carcinogens by surrogate measures in questionnaire or personal interview data. The inexactness of this estimation, magnified by the long interval of time between putative exposure(s) and cancer detection, has obscured or limited identification of cancer etiologies. Biomarkers of exposure (e.g., blood levels of pesticides) and effect (e.g., DNA adducts) promise to be potentially applicable in studies of carcinogenesis. Methodological issues, including exposure measurement error, and research gaps in exposure assessment for studies in environmental/occupational epidemiology have been a continuing concern during the past decade (2-5). The pivotal role of exposure assessment in evaluating health effects of the environment has led to collaborative, coordinated efforts by several Federal agencies, e.g., NIH institutes, Centers for Disease Control and Prevention (CDC), and U.S. Environmental Protection Agency (EPA), to jointly support the expansion and improvement of this science. In September 1999 a trans-NIH workshop, The Role of Human Exposure Assessment in the Prevention of Environmental Disease, organized by NIEHS, addressed the current status and opportunities for exposure assessment, using examples of health effect studies in chronic diseases, cancer, and reproductive health. The first result of the workshop discussions is RFA ES-00-009 (6), a request for SBIR (Small Business Innovation Research) applications in Development of Technology- Driven Products/Devices/ Biomarkers for Measuring Exposure to Environmental Agents. The initiative strives to integrate biotechnology with bioengineering, imaging techniques, and advances in molecular biology to revolutionize the field of exposure assessment. Awards will be funded in fiscal year 2001. An advisory session of interdisciplinary participants within the workshop was also convened by the NCI and NIEHS extramural programs. The group, comprising cancer and occupational/ environmental epidemiologists as well as environmental scientists, identified and discussed immediate research needs (to be achieved within 5 years) for improved exposure assessment in environment-cancer studies. These needs are incorporated in this RFA (refer to the following Research Goals and Scope ) and represent, for NCI, one of the extraordinary opportunities for research investment (Genes and the Environment) in the Bypass Budget for 2002 (7). Research Goals and Scope This initiative proposes to stimulate interdisciplinary research to develop, test, validate, and compare technology, methods, and biomarkers that could provide more accurate estimates of retrospective and current environmental exposures (e.g., chemical and physical substances) relevant to cancer development. Quality control strategies should be included. Collaborations that may include multicenter study sites, established infrastructures for resources such as the Cancer Genetics Network, the Cancer Family Registries, other registries, large cohort populations or case series, and interactions between NIH/NCI intramural and extramural scientists are encouraged. Applications will be welcomed from researchers participating in ongoing collaborative organizations such as the NCI Specialized Programs of Research Excellence (SPORES), the NIEHS Environmental Health Sciences Centers, NIEHS/EPA Children’s Health Centers, and NIEHS Superfund Basic Research and Training Program. Investigations in understudied populations and in populations with contrasting exposures, including those who are residing outside of the U.S., are encouraged. Research that is complimentary to or derived from an ongoing investigation (i.e., parent study) may be proposed, contingent upon the continuation of the parent study for at least two years. Examples of topics that may be proposed include, but are not limited to the following (no order of priority although retrospective methods will be of special interest): Technique or method of quantifying exposures o direct measurements and/or technology, cost-effective, reliable and simple, for large-scale population studies o assessment of the effects of space, time, and location on exposure levels o development, validation, and improvement of biomarkers of exposure or effect or as surrogates of exposure, e.g., by time-series and pharmacokinetic data o development and validation of questionnaires to obtain body burden data and cumulative environmental exposures, taking into account confounders and effect modifiers such as age, gender, socio-economic status, and bio-behavioral characteristics o assessment and estimation of low level exposures o statistical methods, e.g., geographic exposure/spatial modeling, exposure ranking systems, modeling of exposure monitoring data, minimizing exposure measurement error Characterization of exposures and exposed populations o exposure reconstruction for retrospective exposures o suitability and requirements for use of biological specimens (e.g., body fluids, surrogate tissue, target tissue) to obtain exposure data, including selection of best measure of the exposure (e.g., chemical agent, metabolites, reactive products) o total exposure profiles for individuals that consider multiple sources (e.g., air, water, food), multiple types (e.g., dermal, respiratory), and multiple sites (e.g., residential, occupational, and/or general environmental) of exposure o characterization of variability in individuals, e.g., body burden, biologically effective dose levels, effect of polymorphisms of metabolizing enzymes o detection and determination of exposure levels to chemical mixtures o small field studies to characterize exposure routes and sources, e.g., use of videotaping and time-activity diaries to assess children’s exposures Correlations, comparisons, and validation o use of group level exposures to estimate individual level exposures with validation o correlation of exposure data from questionnaires and direct measurements o feasibility of utilizing survey data (e.g., National Human Exposure Assessment Survey, NHEXAS), surveillance, and bio-monitoring data MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) exploratory/developmental (R21) grant mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed THREE years. These grants are non-renewable and continuation of projects developed under this RFA will be through the traditional, unsolicited investigator-initiated grant program. Amended applications will be accepted. The earliest anticipated award date is September 30, 2001. Though the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project. Applicants may request up to $125,000 direct costs (five budget modules) per year unless the application includes consortium costs, in which case the limit is $150,000 direct costs (six budget modules) per year. 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 http://grants.nih.gov/grants/funding/modular/modular.htm FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for this program is $2 million. The NCI and NIEHS intend to commit the $2 million in FY 2001 to fund approximately 9 to 12 new grants in response to this RFA. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of NCI and NIEHS 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 applications of outstanding scientific and technical merit. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, research institutions, hospitals, small, minority, and/or women-owned businesses, state and local governments or their bona fide agents, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants are welcome. Inquiries regarding programmatic issues may be directed to: Dr. Kumi Iwamoto Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Boulevard, Suite 5104, MSC Bethesda, MD 20892-7324 Telephone: (301) 435-4911 Fax: (301) 402-4279 Email: iwamotok@mail.nih.gov Dr. Gwen Collman Division of Extramural Research and Training National Institutes of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4980 Fax: (919) 316-4606 Email: collman@niehs.nih.gov Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Suite 8109, MSC 8239 Rockville, MD 20852 (express courier) Bethesda MD 20892 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov Direct inquiries regarding fiscal matters to: Ms. Joy McCauley Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7206 Fax: (301) 496-8601 Email: jm165@nih.gov Ms. Dorothy G. Duke Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-2749 Fax: (919) 541-2860 Email: duke3@niehs.nih.gov LETTER OF INTENT Prospective applicants are asked to submit, by February 19, 2001, 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 RFA 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 NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to the program staff listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. SCHEDULE Letter of Intent Receipt: February 19, 2001 Application Receipt: April 19, 2001 Peer Review Date: June/July, 2001 Review by NCAB Advisory Board: September, 2001 Earliest Anticipated Start Date: September 30, 2001 APPLICATION PROCEDURES The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. Applications 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 301/710-0267, email: grantsinfo@nih.gov. For those applicants with internet access, the 398 kit may be found at: http://grants.nih.gov/grants/funding/phs398/phs398.html. Applicants are strongly encouraged to call the program contacts listed in INQUIRIES above with any questions regarding the responsiveness of their proposed project to the goals of this RFA. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $125,000 per year ($150,000 if there are consortium/contractual costs). 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 http://grants.nih.gov/grants/funding/modular/modular.htm 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 all 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 all 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: http://grants.nih.gov/grants/funding/modular/modular.htm. - 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 RFA and will be returned without further review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the checklist, and three 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 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC 8239 Bethesda, MD 20892-8239 Rockville, MD 20852 (for express/courier service) Applications must be received by April 19, 2001. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the NCI and NIEHS. 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 NCI in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications 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 the applications under review will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board and the National Advisory Environmental Health Sciences Council. 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 methods? 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 The following will be considered when making funding decisions: quality and scientific merit of the proposed project as determined by peer review, programmatic priorities, and the availability of funds. 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 sub- populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm, The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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 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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS Effective October 1, 2000, the NIH requires education on the protection of human research participants for all investigators submitting NIH application for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects. All investigators proposing research involving human subjects should read the above-referenced policy that was published in the NIH Guide for Grants an Contracts, June 5, 2000 (Revised August 25, 2000), and is available at the following URL address http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. 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, Exposure Assessment Methods for Cancer Research, is related to priority area of cancer. 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. 93.393, 93.849, and 93.894. Awards are made under authorization of 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 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. REFERENCES 1. Zahm SH, Fraumeni, Jr. JF, Davis DL. The Avoidable Causes of Cancer in President’s Cancer Panel Conference on Avoidable Causes of Cancer (April 7-8, 1994), Environ Health Perspect 103 (Suppl 8): 129, 1995. 2. Armstrong B and Boffetta P. Measurement of Exposure and Outcome in Epidemiological Studies Used for Quantitative Estimation and Prediction of Risk in Quantitative Estimation and Prediction of Risk in Quantitative Estimation and Prediction of Human Cancer Risks, edit’s Moolgavkar, D Kewski, L Zeise et al. Lyon, France IARC Sci Publ #131: 75-102, 1999. 3. Rothman K. Methodologic Frontiers in Environmental Epidemiology, Environ Health Perspect 101 (Suppl 4): 19-21, 1993. 4. Hatch M and Thomas D. Measurement Issues in Environmental Epidemiology, Environ Health Perspect 101 (Suppl 4): 49-57, 1993. 5. International Workshop on Retrospective Exposure Assessment in Occupational Epidemiologic Studies, edit RA Herrick and PA Stewart in Appl Occup Environ Hyg 6 (No. 6): 417-559, 1991. 6. RFA ES-00-009, Development of Technology-Driven Products/Devices/Biomarkers for Measuring Exposure to Environmental Agents. Application receipt date November 16, 2000. NIH Guide website http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-00-009.html. 7. Opportunity 1: Genes and the Environment in The Nation’s Investment in Cancer Research Bethesda, MD: National Cancer Institute, NIH publication No. 00-4373: 64-68, October 2000.


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