RFA-OH-99-003: MECHANISTIC-BASED CANCER RISK ASSESSMENT METHODS

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

MECHANISTIC-BASED CANCER RISK ASSESSMENT METHODS Release Date: April 15, 1999 RFA: OH-99-003 P.T. National Institute for Occupational Safety and Health National Center for Environmental Research and Quality Assurance National Cancer Institute Letter of Intent Receipt Date: May 26, 1999 Application Receipt Date: July 14, 1999 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 Centers for Disease Control and Prevention (CDC), the United States Environmental Protection Agency (EPA), and the National Institutes of Health, National Cancer Institute (NCI) announce the availability of fiscal year (FY) 1999 funds for grant applications for research related to mechanistic-based cancer risk assessment methods. The following type of grant will be supported: traditional research projects (see "MECHANISMS OF SUPPORT" section). This research focus is part of a priority area identified in the National Occupational Research Agenda (NORA), which was developed in 1996 by NIOSH and its partners in the public and private sectors. NORA provides a framework to guide occupational safety and health research into the next decade not only for NIOSH, but also for the entire occupational safety and health community. The research needs identified in this RFA are consistent with the NORA but are limited to the targeted areas in the "RESEARCH OBJECTIVES" section. HEALTHY PEOPLE 2000 CDC is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a national activity to reduce morbidity and mortality and improve the quality of life. This Request For Applications (RFA) is related to the priority areas of "Occupational Safety and Health" and "Unintentional Injuries." Potential applicants may obtain a copy of "Healthy People 2000" (Full Report, Stock No. 017-001-00474-0 or Summary Report, Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, public and private nonprofit and for-profit organizations and by governments and their agencies; that is, universities, colleges, research institutions, hospitals, other public and private nonprofit and for-profit organizations, State and local governments or their bona fide agents, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations Note: Public Law 104-65 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 which engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant (cooperative agreement), contract, loan, or any other form. FUNDS AVAILABLE Approximately $1.55 million is available to fund the first budget year of five to six grants under this RFA. The approximate amounts that are expected to be available by each Institute are as follows: NIOSH - $0.55M, EPA - $0.7M, and NCI - $0.25M. It is expected that requested budgets would range up to $250,000 in total costs (direct plus indirect) per year. Higher budgets may be requested, but only if a strong justification is provided. Awards are expected to begin in September 1999, although some awards may not begin until FY 2000. Only applications that are found to be of high scientific merit will be considered for funding, and not all of the funds will be spent if there are not enough highly meritorious applications. For NIOSH and NCI, awards will be made for a 12-month budget period within a project period not to exceed 3 years. Continuation awards within the project period will be made on the basis of satisfactory progress and availability of funds in future years. For EPA, initial awards will be made for the full project periods. Approximately $2.0M is available for total funding of all years combined for all projects awarded. Therefore, no continuation awards will be made in future years. MECHANISMS OF SUPPORT The mechanism of support will be the individual research project grant (R01). The total requested project period for an application submitted in response to this RFA may not exceed three years. However, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. 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. Complete and detailed instructions and information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. Applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year (however, see "FUNDS AVAILABLE" for guidance on budget). A typical modular grant application will request the same number of modules in each year. Application budgets will be simplified. Detailed categorical budget information will not be submitted with the application; budget form pages of the application kits will not be used. Instead, total direct costs requested for each year will be presented. Information, in narrative form, will be provided only for Personnel and, when applicable, for Consortium/Contractual Costs. See section on APPLICATION PROCEDURES below. Additional narrative budget justification will be required in the application only if there is a variation in the number of modules requested. There will be no routine escalation for future years. In determining the total for each budget year, applicants should first consider the direct cost of the entire project period. Well-justified modular increments or decrements in the total direct costs for any year of the project that reflect substantial changes in expected future activities may be requested. For example, purchase of major equipment in the first year may justify a higher overall budget in the first, but not in succeeding years. Other Support pages of the PHS 398 will not be submitted with the application. Information on research projects ongoing or completed during the last three years of the principal investigator and key personnel will be provided as part of the "Biographical Sketch." This information will include the specific aims, overall goals and responsibilities and should include Federal and non-Federal support. This information will be used by reviewers in the assessment of each individuals qualifications for a specific role in the proposed project. Following peer review, information about Other Research Support will be requested from the applicant for applications being considered for award. Additional budget information will be requested only under special circumstances. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Research Project Grants (R01) - A research project grant application should be designed to establish, discover, develop, elucidate, or confirm information relating to occupational safety and health, including innovative methods, techniques, and approaches for addressing problems. These studies may generate information that is immediately useful to solve problems or that will contribute to a better understanding of the causes of work-related diseases and injuries. RESEARCH OBJECTIVES Background The goal of NIOSH is to support research essential for setting occupational safety and health priorities and for demonstrating health impairment when promulgating occupational standards. Risk assessment has been most often applied in assessing the risk of carcinogens, often with animal bioassay data. However, evaluation of these procedures has been limited, and questions abound as to whether the resulting risk estimates are reasonable. Risk assessment for noncarcinogens, particularly qualitative approaches, is even less well developed. Improved methods are needed for using animal bioassay data and human health effects data to generate risk estimates for cancer and noncancer effects and injury. The mission of EPA is to protect both environmental quality and human health through effective regulations and other policy initiatives. Achievement of this mission requires the application of sound science to assessment of environmental problems and to evaluation of possible solutions. A significant challenge is to support both long-term research that anticipates future environmental problems as well as research that fills gaps in knowledge relevant to meeting current Agency goals. EPA's research programs focus on reduction of risks to human health and ecosystems and on the reduction of uncertainty associated with risk assessment. Through its laboratories and through grants to academic and other not-for-profit institutions, EPA promotes research in both domains, according the highest priority to those areas in which risk assessors are most in need of new concepts, methods, and data. EPA also fosters the development and evaluation of new risk reduction technologies across a spectrum, from pollution prevention through end-of-pipe controls to remediation and monitoring. In all areas, EPA is interested in research that recognizes issues relating to environmental justice, the concept of achieving equal protection from environmental and health hazards for all people without regard to race, economic status, or culture. The NCI is the principal Federal funding agency that supports laboratory and clinical investigations relating to the cause, prevention, diagnosis, and treatment of cancer. Of special interest are epidemiological studies incorporating molecular technology and/or quantitative methods and methodological developments that can assess the role of occupational or environmental risk factors in the etiology of human cancer. Research Goals Animal bioassay data are frequently used to estimate risks to humans from environmental and occupational exposures to toxic agents in spite of concerns that these assays may have limitations as predictors of human risk. Rodent cancer bioassay data, for example, are generated from late or terminal stages of complex sequences of events and processes that are determined by both genotype and phenotype and can differ considerably between rodents and humans. Also, bioassays are carried out at doses that may exceed relevant human exposures. Risk estimations based on bioassay data, therefore, may not be an accurate reflection of the risks to human health from exposure to toxic agents. In order to more accurately estimate risks to humans from exposures to toxic agents, it is important that risk assessment methods and practices be continually evaluated and improved upon in light of new scientific information. A large body of information that has important consequences for assessing the validity of current methodologies, and implementing their improvement, comes from the fields of molecular and cellular biology. Over the last decade these disciplines have increased our understanding of the basic pathways and processes that control cell growth, differentiation, and death; they have also provided new insights into how these pathways and processes can be subverted by toxic agents. While many pathways and processes are common to all eukaryotic cells, there are clear phenotypic and genotypic differences that can cause toxic responses to be cell type- and species-specific. This can profoundly affect how animals and humans respond to the same toxic agent. These insights into molecular and cellular mechanisms gained over the last decade of basic research need to be incorporated into current risk assessment methods and practices. This RFA solicits studies that focus on the development of cancer risk assessment methods and practices. Emphasis should be on the development of new methods and practices that reduce the uncertainties associated with cancer risk assessment, especially uncertainties that are encountered in extrapolating from animal species to humans. Studies that propose refinement, validation, or invalidation of existing methods and practices are also acceptable if they will result in a significant reduction in uncertainty. Methods development can be based on in vitro and/or in vivo animal model systems, in vitro human cell model systems, and exploratory epidemiologic approaches. Short-term, mechanistic-based methods that can be used to augment long-term bioassays are also encouraged. A clear and unambiguous demonstration of mechanistic commonality with humans is a requirement of any method based on animal model systems. SPECIAL REQUIREMENTS Applicants will be expected to budget for and participate in an annual All- Investigators Meeting with NIOSH, EPA, and NCI scientists in Washington D.C. and other grantees to report on research activities and to discuss issues of mutual interest. Human Subjects If a project involves research on human subjects, assurance (in accordance with Department of Health and Human Services Regulations, 45 CFR Part 46) of the protection of human subjects is required. In addition to other applicable committees, Indian Health Service (IHS) institutional review committees also must review the project if any component of IHS will be involved with or will support the research. If any American Indian community is involved, its tribal government must also approve that portion of the project applicable to it. Unless the grantee holds a Multiple Project Assurance, a Single Project Assurance is required, as well as an assurance for each subcontractor or cooperating institution that has immediate responsibility for human subjects. The Office for Protection from Research Risks (OPRR) at the National Institutes of Health (NIH) negotiates assurances for all activities involving human subjects that are supported by the Department of Health and Human Services. Animal Subjects Requirements If the proposed project involves research on animal subjects, compliance with the "PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions" is required. An applicant (as well as each subcontractor or cooperating institution that has immediate responsibility for animal subjects) proposing to use vertebrate animals in CDC-supported activities must file (or have on file) the Animal Welfare Assurance with the Office for the Protection from Research Risks (OPRR) at the National Institutes of Health. The applicant must provide in the application the assurance of compliance number and evidence of review and approval (including the date of the most recent approval) by the Institutional Care and Use Committee (IACUC). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the Centers for Disease Control and Prevention (CDC) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995. 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 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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. LETTER OF INTENT Prospective applicants are asked to submit, by May 26, 1999, 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 enter into the review of a subsequent application, the information that it contains allows the participating Institutes and Centers to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be submitted to: Roy M. Fleming, Sc.D. National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1600 Clifton Road, N.E. Building 1, Room 3053, MS D-30 Atlanta, GA 30333 Telephone 404-639-3343; Fax 404-639-4616 Email: rmf2@cdc.gov APPLICATION PROCEDURES Applicants must use Form PHS 398 (rev. 4/98). 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 301/710-0267, Email: grantsinfo@nih.gov. Application kits are also available at: grants.nih.gov/grants/forms.htm. BUDGET 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 up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. (However, see "FUNDS AVAILABLE" for guidance on budget.) 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 - Use 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. 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. 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 foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. 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 current position(s) and then previous positions; - List selected peer-reviewed publications, with full citations; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. 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. It is important to identify all exclusions that were used in the calculation of the F&A costs for the initial budget period and all future budget years. o 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. Applicants 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 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. If the proposed project involves organizations or persons other than those affiliated with the applicant organization, letters of support and/or cooperation must be included. Submit a signed, typewritten original, including the checklist, and three signed, clear, and 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 also be sent to Dr. Roy M. Fleming at the address under LETTER OF INTENT. Applications must be received by July 14, 1999. 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 and responsiveness (applicants should clearly indicate which priority area of this RFA is being addressed by their proposal) and will be assigned to the appropriate sponsoring federal agency or institute for funding consideration. Applications determined to be incomplete or unresponsive to this RFA will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA (see "Quality Assurance Narrative Statement" below) will be reviewed for scientific and technical merit by an initial review group. Reviewers will identify those applications with the highest scientific merit, which generally comprise the top half of applications reviewed. Those applications will be discussed fully and assigned a priority score between 100 and 300 (100 is the best possible score). For all other applications, there will be a limited discussion and they will not be scored. Notification of the scientific review results will be sent to the applicants after the initial review. Following the initial review, applications will receive a secondary review for programmatic importance. For applications assigned to EPA, the programmatic review will be conducted within their Agency. For NCI, the review will be conducted by their Council. Review Criteria (also see "Quality Assurance Narrative Statement" below): o Significance - Does this study address an important problem related to the topical research issues outlined in this solicitation? 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? o Approach - Are the conceptual framework, design (including composition of study population), 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? o 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? o 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? o 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 documentation of cooperation from industry, unions, or other participants in the project, where applicable? Is there evidence of institutional support and availability of resources necessary to perform the project? The initial review group will also examine the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders, 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. The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. Review Criteria for Programmatic Importance are as follows: o Magnitude of the problem in terms of numbers of workers affected. o Severity of the disease or injury in the worker population. o Usefulness to applied technical knowledge in the identification, evaluation, or control of occupational safety and health hazards on a national or regional basis. o Propensity to improve understanding of the cause, diagnosis, treatment, and prevention of adverse health or safety outcomes caused by occupational exposures. Quality Assurance Narrative Statement EPA regulations require the inclusion of a Quality Assurance Narrative Statement for any project involving data collection or processing, conducting surveys, environmental measurements, and/or modeling, or the development of environmental technology (whether hardware-based or via new techniques) for pollution control and waste treatment. This statement should not exceed two consecutively numbered, 8.5x11-inch pages of single-spaced standard 12-point type with 1-inch margins. This statement is to be considered as additional information and is not counted against the 25 pages permitted for the Research Plan. The Quality Assurance Narrative Statement should, for each item listed below, either present the required information or provide a justification as to why the item does not apply to the proposed research. For awards that involve environmentally related measurements or data generation, a quality system that complies with the requirements of ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs," must be in place. 1. The activities to be performed or hypothesis to be tested (reference may be made to the specific page and paragraph number in the application where this information may be found); criteria for determining the acceptability of data quality in terms of precision, accuracy, representativeness, completeness, comparability. (Note: these criteria must also be applied to determine the acceptability of existing or secondary data to be used in the project. 2. The study design, including sample type and location requirements and any statistical analyses that were used to estimate the types and numbers of samples required for physical samples or similar information for studies using survey and interview techniques. 3. The procedures for the handling and custody of samples, including sample identification, preservation, transportation, and storage. 4. The methods that will be used to analyze samples or data collected, including a description of the sampling and/or analytical instruments required. 5. The procedures that will be used in the calibration and performance evaluation of the sampling and analytical methods used during the project. 6. The procedures for data reduction and reporting, including a description of statistical analyses to be used and of any computer models to be designed or utilized with associated verification and validation techniques. 7. The intended use of the data as they relate to the study objectives or hypotheses. 8. The quantitative and or qualitative procedures that will be used to evaluate the success of the project. 9. Any plans for peer or other reviews of the study design or analytical methods prior to data collection. ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs" is available for purchase from the American Society for Quality Control, phone 1-800-248-1946, item T55. Only in exceptional circumstances should it be necessary to consult this document. AWARD CRITERIA Final funding decisions are based on the recommendations of the initial (technical merit) and secondary (programmatic importance) reviews, balance of awards across areas of programmatic interest in this RFA, and availability of funds. Awards are expected to begin in September 1999, although some awards may not begin until FY 2000. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. This RFA and other CDC Announcements can be found on the CDC HomePage (www.cdc.gov) under the "Funding" section. This RFA can also be found on the NIOSH HomePage (www.cdc.gov/niosh) under "Extramural Program." Potential applicants may obtain a copy of the "National Occupational Research Agenda" (HHS, CDC, NIOSH Publication No.96-115) from the National Institute for Occupational Safety and Health, telephone (800) 356-4674. It is also available on the internet at "http://www.cdc.gov/niosh/nora.html". Direct inquiries regarding programmatic issues to: Roy M. Fleming, Sc.D. Director, Research Grants Program National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 1, Room 3053, MS D-30 Atlanta, GA 30333 Telephone: 404/639-3343 FAX: 404/639-4616 Email: rmf2@cdc.gov David Reese, Ph.D. U.S. Environmental Protection Agency National Center for Environmental Research and Quality Assurance 401 M. Street, S.W. Washington, D.C. 20460 Telephone: 202/564-6919 FAX: 202-565-2448 Email: reese.david@epamail.epa.gov Kumiko Iwamoto, M.D., Dr.P.H. Epidemiology and Genetics Research Program National Cancer Institute 6130 Executive Boulevard, Room 535 Bethesda, MD 20892-7395 Telephone: (301) 435-4911 FAX: (301) 402-4279 Email: ki6n@nih.gov Direct inquiries regarding grants management matters to: Joanne Wojcik Grants Management Branch Procurement and Grants Office Centers for Disease Control and Prevention 2920 Brandywine Road, Suite 3000 Atlanta, GA 30341-4146 Telephone: 770/488-2717 FAX: 770/488-2777 Email: jcw6@cdc.gov Mr. Jack Puzak National Center for Environmental Research and Quality Assurance U.S. Environmental Protection Agency 401 M. Street. S.W. (8701R) Washington, D.C. 20460 Telephone: 202/565-6825 FAX: 202/565-2444 Email: puzak.jack@epamail.epa.gov Mr. William Wells Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 250 FAX: (301) 496-8601 Email: wellsw@gab.nci.nih.gov AUTHORITY AND REGULATIONS The Catalog of Federal Domestic Assistance number is: 93.262 for the National Institute for Occupational Safety and Health (NIOSH) and 93.393 for the National Cancer Institute (NCI). This program is authorized under the Public Health Service Act, as amended, Section 301(a) [42 U.S.C. 241(a)], and the Occupational Safety and Health Act of 1970, Section 20(a) [29 U.S.C. 669(a)]. The applicable program regulation is 42 CFR Part 52. EPA awards are made under authority of 40 CFR Part 30 and 40. This program is not subject to the intergovernmental review requirements of executive order 12372 or Health Systems Agency Review. SMOKE-FREE WORKPLACE CDC, EPA, and PHS strongly encourage all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products, and Public Law 103- 227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, and early childhood development services are provided to children.

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