RFA-ES-98-004: DEVELOPMENTAL GRANT: ENVIRONMENTAL HEALTH SCIENCES CENTERS

Department of Health
and Human Services (HHS)

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DEVELOPMENTAL GRANT: ENVIRONMENTAL HEALTH SCIENCES CENTERS Release Date: April 17, 1998 RFA: ES-98-004 P.T. National Institute of Environmental Health Sciences Letter of Intent Receipt Date: May 15, 1998 Application Receipt Date: July 17, 1998 PURPOSE The overall intent of this National Institute of Environmental Health Sciences (NIEHS) program is to establish multi-disciplinary research programs supported by Core Centers (P30s) that utilize state-of-the-art science and address as a primary focus environmentally-related health problems of economically disadvantaged and/or underserved populations. The first step in this process is the current RFA, which requests Developmental Center Grant (P20) applications from institutions or consortia of institutions wishing to develop multi disciplinary Core Center (P30) grants with this theme. It is important to note that to be eligible for a Core Center (P30) that would follow after the P20 award period, a minimum of $1,500,000 direct costs of NIH peer reviewed, investigator initiated research support (or its equivalent) in environmental health science must be in place. This research must be directly related to the theme proposed for the Core Center. An NIEHS Core Center conducts novel, interdisciplinary, integrative research on a focused question or issue relevant to the mission of the NIEHS. Such research uses experimental designs and technologies that are at, or exceed, those considered to be state-of-the-art. The present initiative will support early stage development of the requisite interdisciplinary teams to study environmental health concerns of an underserved population, and in doing so, establish the feasibility of working as a cohesive, interactive Core Center. This RFA aims to ensure that the scientific, institutional, geographic, and demographic diversity of the NIEHS Center program is maintained by encouraging new research-oriented institutions to develop the research, leadership, and organizational capabilities expected of an NIEHS Core Center. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Developmental Grant: Environmental Health Sciences Centers, is related to the priority area of environmental health. Potential applicants may obtain a copy of "Healthy People 2000: (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00471-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone: (202) 512-1800. ELIGIBILITY REQUIREMENTS Applicants must have a minimum of $500,000 in funded research related to environmental health sciences to be eligible for this solicitation. A Developmental Center is appropriate for those groups of investigators that show evidence of a strong track record in environmental health research, through support of individual research project grants, and show promise, by virtue of institutional commitment and identification of a research focus, to develop into mature Core Centers. An institution with little or no peer reviewed, extramurally funded research activity in environmental health science would not be eligible for a Developmental Center. Applications may be submitted by domestic for-profit and non-profit organizations, both public and private including predominately minority institutions, individually or as joint efforts of minority institutions and majority institutions. Usually, only one developmental grant will be funded at an institution. While a single institution must be the applicant, a multi- institutional arrangement (consortium) is possible if there is a compelling reason for it and if there is clear evidence of close interaction among the participants. The NIEHS has a significant commitment to the support of programs designed to increase the number of under-represented minority scientists participating in biomedical and behavioral research. Therefore, applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT It is important to stress that award of P20 Developmental Grants will be highly competitive. These awards will be made to only those institutions able to demonstrate to the review committee a high likelihood of success in following the P20 grant period with a competitive core center grant application. Therefore, requirements established by the NIEHS for its Core Center must be considered attainable by applicants for the P20 award. The NIEHS has available upon request the guidelines for these applications (P30) and potential applicants for the P20 award are encouraged to obtain a copy. This RFA is a one-time solicitation. FUNDS AVAILABLE The funding level for NIEHS Developmental Center grants will be $250,000 direct costs per year for a maximum of four years. It is anticipated that one to three developmental grants will be awarded, depending upon the appropriation of funds for this purpose and the quality of the applications received. Awards are not renewable and supplements are not allowed. The earliest possible award date is April 1, 1999. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory progress during the preceding year and upon availability of funds. RESEARCH OBJECTIVES Background Most Americans want to live long and healthy lives, and the majority of them achieve that goal. In general, however, members of economically disadvantaged and/or underserved populations suffer disproportionate levels of morbidity and mortality. The socioeconomically disadvantaged suffer the lowest life expectancy and highest adverse health consequences of inadequate access to high-quality health care. Additionally, they are most often the populations with the highest degree of exposure to environmental agents and are frequently the populations with the least information available as to the health consequences of exposure to these agents. Research efforts to identify the sources of hazardous environmental exposures and their effects among minority and underserved populations have been insufficient. Not much is known about the types of environmental agents to which socioeconomically disadvantaged groups within our population are exposed at home and on the job. There has been little research to see how exposure to these agents varies with socioeconomic status. It is reasonable to hypothesize that factors such as malnutrition, health status, socioeconomic status, in combination with behaviors such as smoking, alcohol consumption and drug use play important roles in the dose response, metabolism and health effects of these hazardous agents among the population. Exposures to harmful environmental agents may be more prevalent among the socioeconomically disadvantaged because of the employment opportunities available to them and the conditions in which they work. Occupational exposures vary greatly with job responsibility. The lowest paying jobs in industrial plants are usually the most risky. Furthermore, a high percentage of certain jobs may be held by one racial group. Geographic location also plays an important role in environmental exposure of socioeconomically disadvantaged populations. Inner city poor often live in homes with high lead levels. These populations may also be exposed to higher levels of air pollution. On the other hand, toxic wastes are more frequent in rural, low socioeconomic counties in the U.S., where nuclear facilities and chemical plants are often located. Disadvantaged neighborhoods may rely on well water, which may be polluted with toxic chemicals. Medical care is often inadequate or unavailable to a significant proportion of the socioeconomically disadvantaged and minority populations in America today. This is in conjunction with the fact that many chronic diseases and other medical problems associated with exposure to environmental agents are highly prevalent in segments of the population which are economically disadvantaged. Lead poisoning and the cognitive and developmental damage associated with exposure to lead occur disproportionately among minority populations. High blood pressure and prostate cancer are very common among Blacks. Low birth weight babies and other problems during pregnancy are common among groups of women who do not have access to good prenatal care. Some of these conditions or other diseases may have an environmental component in their etiology. The lack of resources for early identification of the effects of toxic agents in these subgroups may lead to an increased disease burden in a population economically least able to cope with it. Recent progress and opportunities Prominent among the goals of the NIEHS are the achievement of environmental justice for all populations as well as enhancing participation of minority populations within the mainstream of biomedical research science. Both of these goals have a clear benefit to the health of the nation and provide a means of addressing a potential labor shortage in the twenty-first century. As one continuing aspect of this effort, the Institute is requesting submission of Developmental Center grant applications that focus on environmentally related health problems of socioeconomically disadvantaged populations. The following are examples of existing NIEHS Developmental Centers. COLUMBIA UNIVERSITY SCHOOL OF PUBLIC HEALTH Considering that underprivileged Americans, particularly those of color, are disproportionately exposed to environmentally hazardous conditions in their communities, Columbia University established the Center for Environmental Health in Harlem. The Center fosters research aimed at diseases caused or exacerbated by environmental factors and translates research findings into public policies and educational programs to increase public awareness concerning environmental health concerns. Community organizations and local physicians have identified asthma as the single most important public environmental health problem. The Center has worked with community members and organizations to launch new research to determine the impact of vehicular traffic, particularly diesel buses, and various point sources of air pollution on air quality in Harlem. This is a model research project as it was conceived by the community, deemed to be important by Center scientists, and now involves student interns from the community. Air quality and asthma incidence data will be mapped and interventions which minimize both outdoor and indoor triggers of asthma will be assessed. At the same time, novel molecular studies of antibody (IgE) formation have been initiated in an effort to elucidate biological markers of asthma susceptibility and disease. TULANE UNIVERSITY An NIEHS Developmental Center has been established to assist researchers at the Tulane/Xavier Center for Bioenvironmental Research to focus their studies on issues of environmental health effects in minority and other underserved populations. The Center has provided funds for pilot projects to encourage and expand research and outreach activities in this area, especially on the part of junior faculty in both institutions. An ongoing population-based study is targeting a small semi-rural community in south central Louisiana to assess the impacts of chemical air pollutants from community-based manufacturing facilities. The study includes modification, testing and validation of instruments to assess the prevalence of respiratory symptoms among residents of the community. It also identifies and monitors facilities which may be sources of air pollutants and determines their proximity to the population. Dispersion modeling is utilized to determine general exposure to toxicants. Results from statistical analysis will illustrate the prevalence of respiratory symptoms with respect to proximity to the source of pollutants. UNIVERSITY OF LOUISVILLE A significant number of women and minorities reside and/or are part of the workforce in industrial areas in Louisville. These industrial populations are exposed to three major classes of toxins which are used in local industry: (1) acrylonitrile and related compounds used in synthetic rubber production, (2) vinyl chloride and related compounds used in the production of plastics, and (3) diverse metal catalysts employed in various industrial processes. Considering this fact, the University of Louisville Center for Environmental Health Sciences was established to stimulate interdisciplinary research in the environmental health sciences and to expand education and outreach to the public, industry, and local and state governments in Kentucky. Researchers at the Center are developing molecular biomarkers as human health indicators of industrial chemical exposure. The Center outreach program is assessing the risk of exposure to chemicals of underrepresented individuals. Specifically, the Center has established a biological specimen bank and has implemented a Residential Surveillance Project to ascertain exposure and risk of underserved populations in West Louisville. To help translate research findings into sound public policy, the Center has offered its services to provide data evaluating the level of exposure of individuals to the effluent from Louisville industries. Center officials have also initiated contacts with the management industries, unions, and ministerial associations in West Louisville to enhance communication among all involved parties. Relationship to Environmental Justice Activities conducted under this announcement should be consistent with Federal Executive Order No. 12898 entitled, "Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations." To the extent practicable and permitted by law, grantees shall make achieving environmental justice part of their project’s mission by identifying and addressing, as appropriate, disproportionately high and adverse human health effects of environmental contaminants on minority and low-income populations. Objectives and Scope Despite the many successes demonstrated by existing NIEHS Developmental Centers, there remains a widespread need for scientific study and outreach activities in underserved communities. Moreover, interdisciplinary research is paramount to enhancing our understanding of the causes and mechanisms of environmentally related disorders. Nevertheless, interdisciplinary research is often difficult to execute. Based on these considerations, the primary purpose of the NIEHS Developmental Center grant (P20) is to provide support for a group of investigators to develop interdisciplinary collaborations, obtain preliminary results to demonstrate feasibility, and develop a research program focused on the goals of this announcement. The resulting program will then be used as the basis for an application for an NIEHS Core Center grant (P30). The components of an NIEHS Developmental Center Grant may include, but are not limited to: 1. Preliminary or feasibility studies to gather sufficient data to demonstrate the potential of ideas or the validity of approaches, to acquire or demonstrate technical competence, or to evaluate other technical factors involved in development of projects that address the goals of this announcement in conjunction with the goals of the NIEHS Center program. 2. Recruitment of new investigators whose expertise would strengthen the Core Center grant application that will be submitted later. 3. Inter- or intra-institutional planning to develop research strategies, including the establishment of a timetable or milestones for the subsequent Core Center grant application. It is important to note that the award of a Developmental Center grant by the NIEHS does not imply a commitment to future funding of any programs planned with the support of such a grant. Separate applications must be submitted for such programs and such applications will be evaluated on the basis of their own merits. SPECIAL REQUIREMENTS In order to ensure that Developmental Center grants remain focused on appropriate goals and make sufficient progress towards establishing the interdisciplinary effort needed to apply for an NIEHS Core Center, frequent programmatic assessments will be necessary. In addition to yearly staff review through progress reports, the directors of Developmental Center grants will be expected to attend periodic meetings of the Environmental Health Science Center Directors. ELEMENTS OF A DEVELOPMENTAL EFFORT The following elements are essential in the planning and subsequent development of an NIEHS Center: 1. Center director: A senior level person with clear leadership and administrative experience should be assigned the responsibility for directing the planning and developmental effort. This person should devote a significant proportion of his/her time to this endeavor. The Director will be the Principal Investigator of the P20 Developmental Center grant application. The Director should be adept in the allocation of time for direction, planning, and development of research activities of the Center and he/she should have sufficient authority to utilize space in the institution to promote the research capabilities of the Center. The Director should also be capable of shaping the body and character of the Center through the naming of new members and discontinuing membership status, when appropriate. 2. Advisory committees: An internal planning committee should assist the Director to stimulate collaboration among constituent programs to take maximum advantage of the institution’s research capabilities. Committee members should be selected from within the Institution(s) developing the Center. Additional members from the community may be selected where appropriate. This committee should evaluate scientific, medical, institutional, and regional considerations and make sure that all available resources are considered in the planning process. In addition, an external advisory group, consisting of senior individuals who are familiar with the functions and organization of NIEHS Core Centers, should be assembled and convened periodically to give the Director knowledgeable advise on the development of a research center as well as an unbiased and independent assessment of the Center’s progress to date and its objectives and plans for the future. 3. Research program definition and implementation: Research programs which are to comprise the Center should be defined in terms of relevance to the environmental health problems of an underserved population. It is expected that a Center will be organized specifically to address innovative, creative, and potentially high risk/high impact research questions. Proposed pilot projects should be multidisciplinary in nature and may focus on basic, clinical, or prevention investigations. Interdisciplinary coordination and collaboration should strengthen and maximize scientific productivity. Projects should build on the current strengths of the institution. Mechanisms may also be developed to translate research results into knowledge that can be applied to public health. Results of research performed at the Center should impact positively on the populations served by the Center in its geographic area. ALLOWABLE COMPONENTS OF NIEHS DEVELOPMENTAL CENTER GRANT (P20) APPLICATIONS Each applicant should consider the strengths and weaknesses of the planned research group plus the expertise and the preliminary data that would be required to demonstrate the technical competence necessary for a successful interdisciplinary Center grant application. 1. Pilot projects/Feasibility studies. Research projects of limited scope to generate data needed to demonstrate technical feasibility, such as access to study populations and to validate an experimental approach, may be proposed. Costs required for carrying out individual projects may be requested. 2. Organizational development. The goal of the P20 grant is to bring together the individuals and organizational structure that will lead to a successful P30 application. Therefore, partial salary support as an incentive for the recruitment of faculty who will be part of the subsequent P30 application is acceptable. 3. Administrative/Planning core. Each Developmental Center must designate a Director who will be the key figure in the scientific planning and subsequent administration of the proposed NIEHS Core Center. Planning efforts should be described in terms of how the necessary feasibility studies, recruitment of new investigators, establishment of new collaborations, and other components will strengthen and broaden any existing programs in the research area of the proposed Center. An internal steering committee is strongly recommended. An external advisory committee is required and must be in place at the time of application submission. Funds may be requested for the purpose of obtaining outside advice and for necessary administrative personnel. NON-ALLOWABLE COSTS FOR NIEHS DEVELOPMENTAL CENTER GRANTS The Center mechanism may not be used as a substitute for individual grant support. It is expected that investigators participating in Centers will have independent support. Funds from these grants may not be used to provide salary and support for central institutional administrative personnel usually paid from institutional overhead charges. Generally, funds for renovation of existing facilities or to purchase substantial amounts of equipment will not be allowed. If such requests are made, they must be justified in terms of the critical nature of the equipment for the success of the overall objectives of the Developmental Center grant, rather than for the planned Core Center grant. 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 is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-42). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. Investigators may also obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by May 15, 1998, 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 consultants, the 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 the subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows review staff to estimate the potential review workload and to avoid conflicts of interest in review. The letter of intent is to be sent to: Ethel B. Jackson, D.D.S. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 111 T. W. Alexander Drive, EC-24 Research Triangle Park, NC 27709 Telephone: (919) 541-7826 FAX: (919) 541-2503 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used to apply for these grants. These forms 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: ASKNIH@od.nih.gov. 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. Although not a prerequisite for applying, applicants are encouraged to consult with NIEHS staff concerning the technical and substantive aspects of preparing the application. Applicants should contact NIEHS staff by phone early in the preparation process. However, applicants should understand that advice given by staff is independent from the review process. As a guideline, it is suggested that approximately ten pages will be sufficient to describe the planned mission and structure of the proposed projects and three to five pages to describe each feasibility study or other activity. Each project should be presented in the format used for an NIH research project grant (R01), but in greatly abbreviated form. If IRB or IACUC review is unavoidably delayed beyond submission of the application, a follow-up IRB certification and/or IACUC verfication signed by the appropriate committee official must be sent to and received by the Scientific Review Branch, NIEHS by September 17, 1998. If IRB certification and/or IACUC verification is not received by September 17, 1998 the application will be considered incomplete and returned to the applicant. Submit a signed, typewritten original of the application, 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 services) At the time of submission, two additional copies of the application must also be sent to: Ethel B. Jackson, D.D.S. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 111 T.W. Alexander Drive, EC-24 Research Triangle Park, NC 27709 Telephone: (919) 541-7826 FAX: (919) 541-2503 Applications must be received by July 17, 1998. If an application is received after that date, the Center for Scientific Review (CSR) will return it to the applicant. 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. In addition, 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 NIEHS staff. Incomplete and/or nonresponsive applications will be returned to the applicant without further considerations. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be noncompetitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. REVIEW CRITERIA These awards will be made to only those institutions able to demonstrate to the review committee a high likelihood of success in following the P20 grant period by a competitive Core Center grant application (P30). The following is not a complete listing of Core Center requirements, but rather is meant to highlight major requirements for applicants for P30 Centers. o A minimum of $1,500,000 direct costs of NIH peer reviewed, investigator initiated research support (or its equivalent) that is directly related to the Core Center research focus and to the mission of the NIEHS. o A demonstrated institutional commitment to the Core Center. o A program cohesiveness that clearly indicates that the presence of the Core Center makes a significant difference to the individual research projects by providing and fostering a high degree of synergy among the various research projects. The major review factors listed below will be used in evaluation of applications for NIEHS Developmental Center grants: 1. Overall Program o Ability to demonstrate a high likelihood of success in following the P20 grant period by a competitive Core Center grant application (P30). o Scientific merit of the program as a whole and development of a well-defined central research focus of clear importance and relevance to the goals of this initiative and the mission of the NIEHS. o Adequacy of the initial research agenda and of the planning mechanism for elaborating a long-term research agenda for the institution. o Appropriateness of Center approach. Whether or not a Center will add significantly to what is or could be done through other modes of research support. Interdependence and synergy of projects and investigators. 2. Administration and Planning Core o Scientific and administrative leadership ability and experience of the Center Director and his/her commitment and ability to devote adequate time to the effective management of the Center. o Appropriateness and adequacy of multi disciplinary teams constituting the Center’s members. o Proposed administrative organization to conduct the following: o Organize and maintain internal communication and cooperation among investigators involved in the Center. o Establish a management structure that includes fiscal administration, procurement, property and personnel management, planing budgets, etc. o Develop a mechanism for selecting and/or replacing professional or technical personnel within the Center. o Obtain regular direction and guidance from internal and external advisory committees. 3. Pilot/Feasibility Studies o Scientific and technical quality of proposed pilot project/feasibility studies. Note: Reviewers will not vote on the merit of each study. The overall quality of the proposed pilot project/feasibility studies will be taken into account in arriving at an evaluation of the application). o Development of an appropriate and adequate review committee and process to assess the scientific merit of future pilot project/feasibility studies within the grant period. 4. Institutional Commitment o Institutional commitment to the program, including lines of responsibility for the Center, and the institution’s contribution to the management capabilities of the Center. o Degree of institutional contribution towards expenses for the Administrative and Planning Core and/or to the proposed pilot project/feasibility studies. o Academic environment and resources in which activities will be conducted, including availability of space, equipment, and facilities, and potential for interaction with scientists from other departments and schools. o Institutional commitment to any newly recruited individuals responsible for conducting essential Center functions and activities. AWARD CRITERIA The following will be considered in making funding decisions: 1. Quality of the proposed applications as determined by peer review. 2. Responsiveness to the goals of this RFA and the mission of the NIEHS. 3. Availability of funds. Although this program is provided for in the financial plans of the NIEHS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory progress during the preceding year and upon availability of funds. Schedule The following is the schedule planned for this initiative. It should be noted that this schedule may be changed without notification due to factors that were unanticipated at the time of the RFA. Contact the Program Official listed under INQUIRIES regarding any changes in the schedule. Letter of Intent Receipt Date: May 15, 1998 Application Receipt Date: July 17, 1998 Initial Scientific Review: October/November 1998 Advisory Council Review: January 1999 Anticipated Date of Award: April 1, 1999 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries regarding programmatic issues to: Allen Dearry, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 111 T. W. Alexander Drive, EC-21 Research Triangle Park, NC 27709 Telephone: (919) 541-4500 FAX: (919) 541-4937 Email: dearry@niehs.nih.gov Direct inquiries regarding fiscal matters to: Mr. David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 111 T. W. Alexander Drive, EC-22 Research Triangle Park, NC 27709 Telephone: (919) 541-1373 FAX: (919) 541-2860 Email: mineo@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.894. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 100-607) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. The program is not subject to the intergovernmental review requirements of Executive Order 12972 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant and contract recipients to provide a smoke free workplace and promote the non use of all tobacco products. In addition, Public Law 103 227, the Pro Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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