ENDOCRINE DISRUPTORS: EPIDEMIOLOGIC APPROACHES Release Date: June 12, 2000 RFA: OH-01-001 National Institute for Occupational Safety and Health (NIOSH), Center for Disease Control and Prevention (CDC) National Center for Environmental Research (NCER), U.S. Environmental Protection Agency (EPA) National Cancer Institute (NCI), National Institutes of Health National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health Letter of Intent Receipt Date: August 11, 2000 Application Receipt Date: September 22, 2000 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 This joint interagency program by NIOSH, EPA, NIEHS, and NCI will support research on the relationship between exposure to endocrine disruptors and adverse health effects in humans, particularly reproductive and developmental, with a focus on epidemiologic approaches. The following type of grant will be supported: traditional research projects (see MECHANISMS OF SUPPORT section). HEALTHY PEOPLE 2010 The cooperating agencies are committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a national activity to reduce morbidity and mortality and improve the quality of life. This announcement is related to the focus area of Occupational Safety and Health. For the conference copy of Healthy People 2010, visit the internet site: http://www.health.gov/healthypeople. 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, including 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. Please note that EPA funding will not be available to foreign organizations, Federal government agencies or for-profit 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. MECHANISM OF SUPPORT The funding mechanisms to be used to assist the scientific community in participating in this grant program will be those of: 1) the National Institutes of Health (NIH) investigator-initiated research project grant (R01); or 2) the Environmental Protection Agency's Office of Research and Development STAR (Science to Achieve Results) program, administered in accordance with 40 CFR Part 30 and 40. Regardless of the mechanism for the award, all applicants should use the PHS 398. Policies that govern grant award programs of each agency will prevail for respective sources of support. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Applications which request up to $250,000 per year in direct costs must be submitted in the modular grant format. Applications requesting budgets greater than $250,000 must submit detailed budget information with the application. For administrative reasons, the primary assignment of all applications will initially be to the NIOSH. After discussion with the other participating programs, applications will be reassigned where they are programmatically most appropriate. AVAILABILITY OF FUNDS Approximately $6 million is available in FY 2001 to fund the first budget year of 9-12 grants under this RFA. 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. Although this program is provided for within the financial plans of the NIOSH, EPA, NCI, and NIEHS awards pursuant to this RFA are contingent upon the availability of funds for this purpose. It is anticipated that awards will be made for a 12-month budget period within a project period not to exceed four years. Continuation awards within the project period will be made on the basis of satisfactory progress and availability of funds in future years. Awards are anticipated to range from $400,000 to $600,000 in total costs (direct and facilities and administrative) per year. Applicants should include in their budgets funds for one trip per year for an annual meeting of grantees to be held in Washington, DC. RESEARCH OBJECTIVES Background Concerns have been expressed in both the lay and scientific communities that some synthetic chemicals used or manufactured in the workplace and released into the environment may be causing adverse health effects in humans through their ability to interfere with the function of the endocrine system. These chemicals are collectively called Endocrine Disruptors (EDs) or Endocrine Disrupting Chemicals (EDCs) and are also referred to as hormonally active agents. They are thought to interfere with one or more aspects of the normal endocrine functions that are responsible for the maintenance of homeostasis and the regulation of developmental processes. The cooperating agencies support research that examines human health consequences of exposure to physical and chemical toxicants in the environment and in occupational settings as well as the underlying mechanisms involved in environmentally related disease and dysfunction. Research on endocrine disrupting chemicals is a priority established by the Committee on Environmental and Natural Resources of the National Science and Technology Council, and the results obtained under this program should assist NIOSH in establishing occupational safety and health priorities and EPA in protecting human health and the environment. Research Goals Despite considerable public interest and research activity, the scope and magnitude of the impact of putative EDCs on human health are largely unknown. In wildlife, a number of adverse effects have been linked to specific EDCs (Kavlock, et. al., Environ. Health Perspectives 104, Supp. 4:715-740, 1996). Exposures in some cases, however, have been unusually high, such as those from chemical spills or sewage out falls, and thus are not typical of the ambient exposures normally encountered by wildlife or human populations. In humans, an even greater uncertainty exists. While it has been speculated that some endocrine-related diseases or conditions, such as breast and prostate cancer, decreased sperm counts, and hypospadias are caused by EDC exposure; no linkage has been established to date between exposure to a specific environmental EDC and an adverse health effect in humans. Research applications are sought which will investigate the relationships between exposure to endocrine disruptors and adverse health effects, particularly reproductive/developmental effects in humans. For the purposes of this RFA, an endocrine disruptor is an exogenous agent found in the workplace or environment that can interfere with the function of the endocrine system. Studies may be conducted in working populations or the general population. Applications must include study designs that clearly differentiate exposure categories. Applicants are strongly encouraged to design studies that include a range of exposure levels; employ quantitative exposure assessment methodologies, such as biomarkers, that allow differentiation in exposure; allow estimation of timing of exposure in relation to outcomes; and control for other risk factors, such as existing medical conditions and lifestyle factors. Studies are specifically solicited that attempt to demonstrate quantitative relationships between chemical exposures and adverse effects in humans. Effects of interest include but are not limited to the following: 1) reduced fertility in exposed male and females or other indications of altered reproductive function such as changes in hormone levels, menstrual function, endometriosis or poor semen quality; 2) pregnancy outcomes and pre- and postnatal development of offspring of exposed women such as reproductive tract malformations; 3) evidence of latent effects on reproduction among offspring exposed in utero; such as infertility in both male and female offspring and decline in sperm count and semen quality; 4) hormonally mediated cancers of the reproductive tract and sex accessory glands and tissues among offspring exposed in utero; such as testicular cancer; and 5) endocrine related malignancies, such as breast and prostate cancer, in individuals exposed to exogenous EDCs. Applications that investigate members of chemical classes (e.g. phthalates, polybrominated diphenyl ethers, and endocrine-active fungicides, insecticides, and herbicides) that have not been extensively investigated for endocrine disrupting activity in humans are encouraged for this RFA. However, applications that address new approaches (e.g. new cohorts, methods of analysis, or biological endpoints) for studying previously studied chemicals (e.g. dioxins, dibenzofurans, DES, and polyhalogenated biphenyls) are also welcome. Applications that are collaborations between bench, clinical and field epidemiologist scientists are especially encouraged. HUMAN SUBJECTS REQUIREMENTS 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. All applications must follow this policy. 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 PHS-supported activities must file (or have on file) the Animal Welfare Assurance. 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). All applications must follow this policy. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the cooperating agencies (CDC, NIH, and EPA) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in 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 exists 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 and EPA that children (i.e., individuals under the age of 21) must be included in all human subjects research they conduct or support, unless there are scientific and ethical reasons not to include children. 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. URLS IN CDC, EPA or NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for funding must be self-contained within specified page limitations. Unless otherwise specified in the 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. LETTER OF INTENT Prospective applicants are asked to submit, by August 11, 2000, a letter of intent that includes the number and title of the RFA, 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. 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 NIOSH staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent to: Ms Ann Cronin Review Activity Office of Extramural Coordination and Special Programs 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 404-639-2277; Fax 404-639-0035 Email: axc2@cdc.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used for these grants. These forms are available at most institutional offices of sponsored research and 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. The forms may also be downloaded from the Internet at: http://grants.nih.gov/grants/funding/phs398/phs398.html Specific application instructions for this RFA 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 Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. HOWEVER, IF THE DIRECT COSTS REQUESTED EXCEED $250,000 IN ANY YEAR, THE MODULAR GRANT FORMAT CANNOT BE USED. 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. In preparing Modular Grant Applications, the standard instructions for the R01 mechanism should be generally followed: with these specific modifications reflecting modular budget and just-in-time concepts: Modular Grant Instructions Modular Grant applications must 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 and not be formatted as a modular grant application. The total direct costs must be requested in accordance with the program guidelines for the individual R01 mechanism described in this RFA. Applications accepted for funding by EPA will require a detailed budget at the time of award. Successful applicants will be contacted by EPA regarding this requirement. 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 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. Provide an additional narrative budget justification for any variation in the number of modules requested. o PERSONNEL - 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. o CONSORTIUM/CONTRACT COSTS - 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/organization 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. 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, for ongoing research projects and those completed during the last three years, and - list selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If an 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. o Page Limitation - Page limitations for the R01 applications are as stated for the PHS 398 instructions for this mechanism. o Appendix - An appendix or additional supporting materials will not be accepted with the exception of originals of photos used in the application. o Contact - 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. o Special Notes 1. Applications not conforming to these guidelines will be considered unresponsive to this RFA and will be returned without further review. 2. After the completion of the peer review process, applications recommended for funding by EPA will require a detailed budget. Successful applicants will be contacted by EPA regarding this requirement. Just in Time Instructions 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 individual’s 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. Quality Assurance Statement - All applications must include this information. EPA regulations require the inclusion of a Quality Assurance 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. Discuss the activities to be performed or hypothesis to be tested and criteria for determining acceptable data quality. (Note: Such criteria may be expressed in terms of precision, accuracy, representativeness, completeness, and comparability. These criteria must also be applied to determine the acceptability of existing or secondary data to be used in the project.) 2. Describe the study design, including sample type and location requirements, any statistical analyses that were used to estimate the types and numbers of samples required for physical samples, or equivalent information for studies using survey and interview techniques. 3. Describe the procedures for the handling and custody of samples, including sample collection, identification, preservation, transportation, and storage. 4. Describe the procedures that will be used in the calibration and performance evaluation of the sampling and analytical methods and equipment to be used during the project. 5. Discuss 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. 6. Describe the quantitative and/or qualitative procedures that will be used to evaluate the success of the project, including 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. SPECIAL REQUIREMENTS This RFA is a joint announcement by NIOSH, EPA, NCI, and NIEHS and reflects our common research interest. The program will be managed by the four agencies as a unified program, although the grants will be awarded by each agency separately. Applicants will be expected to budget for and participate in an annual All-Investigators Meeting with NIOSH, EPA, NCI, and NIEHS scientists and other grantees to report on research activities and to discuss issues of mutual interest. 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. The sample RFA label is available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf and has been modified to allow for this change. Please note this is in pdf format. 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 Ms. Ann Cronin at the address under LETTER OF INTENT. Applications must be received by September 22, 2000. 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 in the project Description (page 2 of application) which priority area of this RFA is being addressed by their proposal). Applications determined to be incomplete or unresponsive to this RFA will be returned to the applicant without further consideration. 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. 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 NIOSH in accordance with the review criteria stated below. 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 the applications under review, will be discussed and assigned a priority score. Following the initial review, applications will receive a secondary review for programmatic importance. For applications assigned to NIOSH and EPA, the programmatic review will be conducted within their Agency. For NCI and NIEHS, the review will be conducted by their Advisory Councils. PEER REVIEW CRITERIA The goals of CDC, EPA and NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application 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 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 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. (Applicants should note the requirement for a Quality Assurance Statement in the application. See APPLICATION PROCEDURES HEADING.) 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? o Quality Assurance Statement - The panel will review the quality assurance statement for completeness and adequacy in addressing the objectives of the EPA Quality Assurance Program. The scientific 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. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: - quality of the proposed project as determined by scientific review, - availability of funds, and - institutional program priority SCHEDULE Letter of Intent Receipt Date: August 11,, 2000 Application Receipt Date: September 22, 2000 Anticipated Award Date: July 1, 2001 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 "Funding Opportunities", the NIEHS HomePage (www.niehs.nih.gov) under "Grants and Contracts , and the NCER homepage (www.epa.gov/ncerqa) under Announcements. 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: Michael J. Galvin, Ph.D. 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: mtg3@cdc.gov David Reese, Ph.D. U.S. Environmental Protection Agency National Center for Environmental Research 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460 Telephone: (202) 564-6919 FAX: (202) 565-2448 Email: reese.david@epa.gov Kumiko Iwamoto, M.D., Dr.P.H. Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Boulevard Building Executive Plaza North (EPN), Room 539 Bethesda, MD 20892-7395 Telephone: (301) 435-4911 Fax: (301) 402-4279 Email: ki6n@nih.gov Gwen Collman, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Science Box 12233, MD EC-21 Research Triangle Park, NC 27709 Telephone: (919) 541-4980 FAX: (919) 316-4606 Email: collman@niehs.nih.gov Direct inquiries regarding grants management matters to: Ms. Joanne Wojcik CDC Announcement No. 01-006 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 U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, N.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 Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-8796 Fax: (301) 496-8601 Email: wellsw@gab.nci.nih.gov Ms. Dorothy G. Duke Division of Extramural Research and Training National Institute of Environmental Health Science Box 12233, MD EC-22 Research Triangle Park, NC 27709 Telephone: (919) 541-2749 FAX: (919)541-2860 Email: duke3@niehs.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), 66.500 for Environmental Protection Agency (EPA), 93.393 for the National Cancer Institute (NCI), and 93.113 and 93.866 for the National Institute of Environmental Health Sciences (NIEHS). 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. LOBBYING RESTRICTIONS Applicants should be aware of restrictions on the use of HHS/EPA funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition, no part of HHS/EPA appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. SMOKE-FREE WORKPLACE CDC, EPA, and NIH 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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