THE ROLE OF THE ENVIRONMENT IN PARKINSON'S DISEASE: CAREER DEVELOPMENT PROGRAMS FOR PHYSICIAN-SCIENTISTS Release Date: September 21, 1999 RFA: ES-00-003 National Institute of Environmental Health Sciences National Institute of Neurological Disorders and Stroke Letter of Intent Receipt Date: November 5, 1999 Application Receipt Date: January 11, 2000 PURPOSE The purpose of this Request for Applications (RFA) is to stimulate the career development of physician-scientists engaged in research on the relative roles of environmental, endogenous neurochemical, and modifying genetic factors in the cause of Parkinson's Disease (PD). Recent evidence from twin studies has shown that genetics plays less of a role and environmental factors a potentially greater role than previously thought in the development of late-onset PD. In response to this finding, the National Institute of Environmental Health Sciences (NIEHS) and the National Institute of Neurological Disorders and Stroke (NINDS) have issued an RFA (ES-00-002) for research project grants for research aimed at elucidating the role of the environment in the development of PD. The results of these immediate investigations will contribute to clarifying the part environmental factors play in the etiology of this disease. It is recognized, however, that long-term progress in research in this area is dependent on developing a cadre of scientists who can carry the state of knowledge to the next level. This is especially true of physician scientists who can relate fundamental and laboratory findings concerning the role of the environment in PD to the human disease state. This RFA for career development applications addresses that priority goal. 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 Request for Applications, The Role of the Environment in Parkinson's Disease: Career Development Programs for Physician-Scientists, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at: http://odphp.osophs.dhhs.gov/pubs/hp2000 ELIGIBILITY REQUIREMENTS Applications may be submitted, on behalf of candidates, by domestic, non-Federal organizations, public or private, such as medical or other institutions of higher education. Minorities, women and individuals with disabilities are encouraged to apply. At the time of award, candidates must be citizens or noncitizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I- 551, or other legal verification of such status). Noncitizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Applicants for both K08 and K23 awards must have a clinical doctoral degree or its equivalent and hold a professional license to practice in this country. Candidates will generally hold the M. D., but other degrees may be appropriate in selective circumstances. Individuals holding other degrees should contact the Institute Program Administrator listed below concerning their eligibility for the RFA. Candidates for the mentored patient-oriented research career development award (K23) also must have completed their clinical training, including specialty and, if applicable, sub-specialty training prior to receiving an award. However, candidates may submit an application prior to the completion of clinical training. Candidates must identify a mentor with extensive research experience. Candidates must be willing to spend a minimum of 75 percent of full-time professional effort conducting research career development and clinical research. Ineligible individuals include current and former principal investigators on NIH research project awards (R01), FIRST Awards (R29), comparable career development awards (K01 or K07), subprojects of program project (P01) or center grant (P50) awards, and the equivalent. Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible. Current and former recipients of Clinical Associate Physicians Award (CAP) support may apply provided they have had no more than 3 years of CAP support by the time of the award. The combined total of CAP plus K23 or K08 support must not exceed 6 years. A candidate may not concurrently apply for a CAP award or any other PHS award that duplicates the provisions of this award nor have another application pending award. K23 and K08 recipients are encouraged to apply for independent research grant support during the period of this award. A candidate for the Mentored Patient-oriented Research Career Development Award may not concurrently apply for any other PHS award that duplicates the provisions of this award nor have another application pending award. FUNDS AVAILABLE The total estimated funds available for support of the mentored clinical career development (K08, K23) award mechanisms in this Request for Applications are $520,000 per year. This level of expenditure is dependent on the type of applications received, the peer-reviewed merit evaluation and the actual available funds. . MECHANISM OF SUPPORT Awards made in response to this Request for Applications will be for applications using the K08 and K23 mechanisms offered by the NIH. The purpose of the Mentored Clinical Scientist Development Award (K08) is to support the development of outstanding clinician research scientists. This mechanism provides specialized study for individuals with a health professional doctoral degree committed to a career in laboratory or field based research. The K08 supports a three, four, or five-year period of supervised research experience that may integrate didactic studies with laboratory or clinically based research. The purpose of the Mentored Patient-oriented Research Career Development Award (K23) is to support the career development of investigators who have made a commitment to focus their research endeavors on patient-oriented research. This mechanism provides support for three to five years of supervised study and research for clinically trained professionals who have the potential to develop into productive, clinical investigators focusing on patient-oriented research. The K08 and K23 mechanisms are described more fully in the NIH Program Training Home Page found at: http://grants.nih.gov/training/careerdevelopmentawards.htm Background While much of the previous research in Parkinson's disease (PD) has focused on the underlying biological processes critical to disease manifestation in the hopes of developing new treatments, the relative roles of environmental, endogenous neurochemical and modifying genetic factors in the cause of neurodegenerative diseases remain unclear. For example, it is not clear whether differences in prevalence rates of Parkinson's disease in various communities are due to the differential distribution of a hypothetical environmental toxicant or are more frequent where a heritable defect is more common. Moreover, analytic epidemiological studies have varied in case and control selection methodology and venues (e.g., clinics, population bases, different countries) partly accounting for the disparate conclusions reached by investigators. New evidence from a recent study showed that there was no statistically significant difference in the incidence of late-onset (over the age of 50) PD between monozygotic and dizygotic twins. This finding indicates a greater role for environmental agents in the etiology of the disease than previously appreciated. However, the relative roles of genetic susceptibility and environmental factors in triggering PD remain to be determined. The reported observation that cigarette smoking has a protective effect on the development of PD illustrates the complex role that exogenous agents play in the development of PD. Other epidemiological studies have implicated pesticide exposure and rural living as risk factors for developing PD. New evidence has emerged from one study showing that long-term occupational exposure to certain combinations of metals is significantly associated with developing Parkinson's Disease (PD). This is the first study to link a 20- year or more occupational exposure to heavy metals with a chronic neurodegenerative disorder. The study also found a link to PD and occupational exposure to herbicides, insecticides and farming. Findings from research using animal models and in vitro techniques have begun to support some of these epidemiological findings. For example, a study in mice investigating the role of organochlorine pesticides in altering normal dopaminergic function has led to the observation that the pesticide, heptachlor, significantly inhibits vesicular uptake of dopamine making the striatial neurons more vulnerable to degeneration. RESEARCH OBJECTIVES The NIEHS convened a Concept Forum on the Role of the Environment in Parkinson's Disease on July 22, 1999 to evaluate the current evidence and identify future research needs in three areas: basic research, epidemiological research, and clinical research. The Forum concluded that elucidating the role of the environment in the etiology of PD is important in developing a better understanding of the disease process for both its prevention and treatment. Therefore, applications are solicited in, but not limited to, the following areas: o Research aimed at understanding the mechanism by which environmental exposure, endogenous susceptibility factors, and increasing age contribute to the etiopathology of PD. Of particular significance may be those approaches that can be used across species from lower animals to humans. Such approaches permit a precise characterization in animal models of alterations arising from defined environmental exposures which can serve as a cogent guide to underlying cellular and molecular mechanisms necessary to support epidemiological studies. o Epidemiological studies targeted to specific environmental agents and/or combinations of factors associated with an increased risk for neurodegenerative disorders. These studies may target populations already characterized in terms of the incidence and risks for neurodegenerative diseases (e.g., farmers with significant exposure to pesticides) and should use advanced techniques in exposure assessment as well as biomarkers of exposure and effect when possible. o Development of biomarkers of preclinical disease to identify those at risk for selected environmental toxicants, and to identify those who would benefit from trials of possibly neuroprotective drugs. o Studies focusing on early disease which help clarify the contributions and attributable risks from environmental or gene/environmental interactions. o Studies developing models of neurodegenerative disease from low-level and/or chronic exposure to environmental agents and synergistic chemical interactions leading to neuronal injury. o Development of genetically modified transgenics or knockout animals to study increased susceptibility to environmentally induced neurodegeneration and the efficacy of therapeutic interventions. o Elucidation of gene-environment interactions using molecular epidemiology tools. o Studies of the cellular and molecular effect of environmental toxins on alterations in oxidative stress, increased mitochondrial mutations and dysfunction and altered protein metabolism including the metabolism of a-synuclein and parkin. o Toxicant-induced paradigms for studying the mechanism of formation and the role of Lewy body and Lewy body-like inclusions and the comparisons of these structures with those seen in idiopathic PD. o Studies on the role of the inflammatory processes in toxicant-induced PD. o Xenobiotics' potential influence on programmed cell death, neural plasticity, or other processes critical to the maintenance of neuronal viability and function. o Potential role of dietary and life style factors, e.g., fat, fiber, iron, antioxidants, alcohol, caffeine, and tobacco as either predisposing or preventive influences. o Studies on the disruption of dopamine function in the substantia nigra by environmental contaminants. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html 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 Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. CHARACTERISTICS OF MENTORED CAREER DEVELOPMENT PROGRAMS (K23 and K08 AWARDS) The elements of K23 and K08 mentored career development programs which set these types of awards apart from a research grant proposal include: Environment: The institution must have a well-established research and clinical career development program and faculty qualified in clinical or basic research to serve as mentors. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. The candidate, mentor, and institution must be able to describe an in-depth, multi disciplinary career development program that will utilize the relevant research and educational resources. Program: K23 and K08 awards provide up to five consecutive 12-month awards. At least 75 percent of the recipient's full-time professional effort must be devoted to the goals of this award. The remainder may be devoted to clinical, teaching, or other research pursuits consistent with the objectives of the award. Both the didactic and the research phases of an award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate. Candidates proposing patient oriented research must demonstrate they have received or will participate in courses such as: data management, epidemiology, study design, hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects. Because of the focus on progression to independence as a researcher, the candidate for a mentored career development award should propose a period of study and career development consistent with her or his previous research and clinical experience. For example, a candidate with limited experience in a given field of research may find a phased developmental program lasting five years that includes a designated period of didactic training followed by a period of closely supervised research experience the most efficient means of attaining independence. A candidate with previous research experience and training may not require extensive additional didactic preparation and a program that focuses on an intensive, supervised research experience may be appropriate. All programs must be tailored to meet the individual needs of the candidate ensuring that he/she will gain the skills and knowledge necessary to initiate and carry out high quality research. The candidate and the mentor are jointly responsible for the preparation of the plan for this program. The sponsor may form an advisory committee to assist with the development of a program of study or to monitor the candidate?s progress through the career development program. The didactic and research components of both phases must develop new knowledge and research skills in scientific areas relevant to the career goals of the candidate. Mentor(s): Candidates must name a primary sponsor (or mentor), who together with the applicant is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Candidates may also nominate co-mentors as appropriate to the goals of the program. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models. Allowable Costs: Salary: The NIEHS and NINDS will provide salary offset of up to $75,000 per year as well as associated fringe benefits for the career award recipient. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. The candidate must devote at least 75% professional effort to the career development program. The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Because the salary amount provided by this award is based on the full-time institutional salary, no other PHS funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career development program. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. Research Development Support: The NIEHS and NINDS will provide up to $25,000 per year for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; (d) statistical services including personnel and computer time. Ancillary Personnel Support: Salary for mentors, secretaries and administrative assistants is not allowed. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. Evaluation: In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone and facsimile numbers of the Principal Investigator, the identities of the proposed mentor and other key personnel, their participating institutions, and the number and title of this RFA. Although a letter of intent is not required and is not binding, and does not enter into the review of a subsequent application, its provision is highly encouraged. The information it contains will allow NIH staff to estimate the workload and avoid potential conflicts of interest in the review process planning. The letter of intent is to be sent to Dr. Linda Bass at the NIEHS at the address given below by the letter of intent receipt date listed at the heading of this RFA. APPLICATION PROCEDURES Applications are to be prepared using Section IV of the grant application form PHS 398 (rev. 4/98). 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 301/435-0714, email: GrantsInfo@nih.gov They may also be downloaded from the Internet at: http://grants.nih.gov/grants/funding/phs398/phs398.html The application must contain the following: o Candidate: The application should outline the nature of the candidate's commitment to a career in patient-oriented or basic research and present evidence of the candidate's potential to develop into an independent investigator. The application should describe the candidate's immediate and long-term career objectives, explaining how the award will contribute to their attainment. A commitment of at least 75 percent effort to the research program is required. o Three sealed letters of recommendation addressing the candidate's potential for a research career. The mentor's statement (see below) must not be included as one of the letters of recommendation. o Career Development Plan: A description of the career development plan, incorporating consideration of the candidate's goals and prior experience. It must describe a systematic plan to obtain the necessary theoretical and conceptual background, in addition to the research experience and skills, necessary to launch an independent career in clinical or basic research. Candidates for the K23 award must describe the availability of courses such as research design, biostatistics, epidemiology, and ethical and regulatory issues at their institution and the integration of these studies into their career development plan. Less experienced candidates may require a phased developmental period in which the first one to two year(s) of the award are largely of a didactic nature followed by a period of intense, supervised research experience. Candidates with more experience at the time of application may need a shorter didactic period and may already have an adequate theoretical background. In any case, the career development plan must be specifically tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a clinical researcher. o Training in the Responsible Conduct of Research: Candidates must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction. No award will be made if an application lacks this component. o Research Plan: The research plan must be described as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. The candidate should consult with the mentor regarding the development of this section. o Mentor's Statement: The application must include a statement from the mentor including information on his or her qualifications in the research area proposed by the candidate and previous experience as a research supervisor. The application must also include information to describe the nature and extent of supervision that will occur during the proposed award period. Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described. o Environment and Institutional Commitment: The sponsoring institution must document a strong, well-established research and training program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator. The institutional statement also must commit to provision of release time from normal clinical, teaching or administrative duties necessary to meet the 75% effort requirement of this award. o Budget: The total direct costs requested must be consistent with the award limits described above. Applicants seeking information on award limits should contact one of the individuals listed in the INQUIRIES section at the end of this announcement. Applicants who will be using the resources within a General Clinical Research Center (GCRC) during the course of the award are requested to include a letter of agreement from either the GCRC program director or the principal investigator with the application. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 of the request for applications must be typed on line 2 of the face page of the application and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application with the Checklist and three photocopies of the signed application, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Linda K. Bass, Ph.D. Scientific Review Administrator Scientific Review Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences PO Box 12233 MD EC-24 Research Triangle Park, NC 27709 Telephone (919) 541-1307 Fax: (919) 541-2503 email: bass@niehs.nih.gov REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Center for Scientific Review and responsiveness to the RFA by NIEHS. Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by a peer review group convened by the NIEHS in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique. Applications may undergo a streamlined review process. In this process, only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the NIEHS and NINDS national advisory councils The following review criteria will be applied: Candidate o Quality of the candidate's academic and clinical record; o potential to develop as an independent clinical researcher focusing on basic or patient-oriented research; and o commitment to a career in research. Career Development Plan o Likelihood that the career development plan will contribute substantially to the scientific development of the candidate; o appropriateness of the content and duration of the proposed didactic and research phases of the award; and o consistency of the career development plan with the candidate's career goals and prior research experience. Training in the Responsible Conduct of Research o Quality of the proposed training in responsible conduct of research. Research Plan o Scientific and technical merit of the research question, design and methodology; o appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills as described in the career development plan; o adequacy of the plan's attention to gender and minority issues associated with projects involving human subjects, and o adequacy of plans for including children, as appropriate, for the scientific goals of the research, or justification for exclusion. Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Nevertheless, a fundamentally sound research plan must be provided. For candidates who require substantial didactic training as part of their program, the research plan may cover less than the full period of the award. Mentor/Co-Mentor o Appropriateness of mentor(s) research qualifications in the area of this application; o quality and extent of mentor's proposed role in providing guidance and advice to the candidate; o previous experience in fostering the development of more junior researchers; o history of research productivity and support; and o adequacy of support for the proposed research project. Environment and Institutional Commitment o Adequacy of research facilities and the availability of appropriate educational opportunities; o quality and relevance of the environment for scientific and professional development of the candidate; o applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program; and, o applicant institution's commitment to an appropriate balance of research and clinical responsibilities including the commitment of 75 percent of the candidate?s effort to research and research related activities. Budget Justification of the requested budget in relation to career development goals and research aims. SCHEDULE Letter of Intent Receipt Date: November 5, 1999 Application Receipt Date: January 11, 2000 Peer Review Date: March, 2000 Council Review: May, 2000 Earliest Anticipated Start Date: July 1, 2000 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o programmatic priorities o availability of funds INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding K08 and K23 programmatic issues to: Carol Shreffler, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Science Box 12233, MD EC-23 Research Triangle Park, NC 27709 Telephone: (919) 541-1445 FAX: (919) 541-5064 Email: shreffl1@niehs.nih.gov Eugene J. Oliver, Ph.D. Division of Stroke, Trauma, and Neurodegenerative Disorders National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 2203 Bethesda, MD 20892 Telephone: (301) 496-5680 FAX: (301) 480-1080 Email: eollc@nih.gov Direct inquiries regarding fiscal matters to: Ms. Jackie Russell Division of Extramural Research and Training National Institute of Environmental Health Science Box 12233, MD EC-22 Research Triangle Park, NC 27709 Telephone: (919) 541-0751 FAX: (919) 541-2860 Email: russell@niehs.nih.gov Mary Graham Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3256 Bethesda, MD 20892 Telephone: (301) 496-7359 FAX: (301) 402-02119 Email: pd23n@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113 and 93.866. The Mentored Clinical Scientist Development Awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52 and Title 45 Part 74, are applicable to this program. This program is not subject to the intergovernmental review requirements of Executive Order 12372 to Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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