RESEARCH ON CO-MORBID MENTAL AND OTHER PHYSICAL DISORDERS RELEASE DATE: January 22, 2002 PA NUMBER: PA-02-047 (This program announcement has been replaced by PA-05-018) EXPIRATION DATE: November 22, 2004. PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute of Mental Health (http://www.nimh.nih.gov/) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE THIS PA This PA replaces PA-99-071. A range of research studies has demonstrated that many individuals suffer from mental and other physical disorders at the same time. The suffering experienced by individuals as a result, and the cost to the nation in lost productivity and health expenditures, is magnified well beyond the suffering and costs associated with either mental or other physical disorders alone. For example, compelling scientific data show that depression co-morbid with heart disease increases mortality beyond heart disease alone. Other examples of co-morbid mental and other physical disorders include anxiety disorders and cancer, panic disorder and asthma, post-traumatic stress disorder and chronic physical disability caused by serious injury, and schizophrenia and diabetes. Co-morbid disorders occur across the lifespan, from early childhood through the oldest segments of our population, including those with terminal physical disorders. Yet the scope and nature of co-morbid mental and other physical disorders remains largely unknown. Limited reliable and valid national or statewide epidemiological data on the incidence and prevalence of these co-morbid disorders exist. Little is known about the mechanisms that link co-morbid mental and other physical disorders, particularly mechanisms that have a relatively large influence on the development of these co-morbid disorders and can also be modified through intervention. Thus, our ability to intervene to prevent or treat adverse co-morbid mental and other physical outcomes is limited. The overall purpose of this program announcement is to expand and to refocus NIMH-supported studies on co-morbid disorders, including, but not limited to, areas traditionally known as "behavioral medicine" or "health psychology." Of interest are epidemiological studies that elucidate the frequency and distribution patterns of co-morbid mental and other physical disorders across gender, racial/ethnic minority groups, and the lifespan, studies of biological, behavioral, and psychosocial risk and protective processes underlying co-morbid mental and other physical disorders to clarify which processes have the greatest relative influence on the development of these disorders and can potentially be modified through intervention, investigations to discover potentially modifiable biological substrates that link co-morbid mental and other physical disorders, including research on, neurotransmitters, neuropeptides, neuromodulators, hormones and other proteins, neural circuits, and neural systems (to include nervous, endocrine, and immune system pathways, e.g., the hypothalamic-pituitary-adrenal axis), initial tests of innovative pharmacological, behavioral, psychosocial, or environmental interventions, research on the efficacy, effectiveness, long- term outcome and safety of preventive, treatment, and rehabilitative interventions across the lifespan, clinical trials and intervention studies targeting functional and symptomatic outcomes adapting pharmacological, psychosocial, behavioral, or environmental approaches individually or in combination, studies to improve the recruitment and retention of individuals with co-morbid disorders in real-world practice settings, and research on the impact of separate organizational systems and different financing mechanism for mental and other physical disorders. Within these broad research areas, emphasis on better understanding basic behavioral processes is encouraged, including processes such as motivation, decision-making, adherence, emotion, cognition, and social interactions between health care providers and consumers. Descriptive studies (e.g., epidemiology, risk and protective factors research) elicited by this program announcement MUST HAVE CENTRAL AND EXPLICIT RELEVANCE TO MENTAL DISORDERS, SYMPTOMS, OR RELATED DISABILITY as reflected in the title, abstract, theoretical framework, specific aims, measures, and analyses. Intervention studies including prevention, treatment, and rehabilitation-- elicited by this announcement should PRIMARILY TARGET MENTAL DISORDER OUTCOMES that are co-morbid with other physical disorders. Examples include preventing or treating mood or anxiety disorders in people with another physical disorder. Interventions may be pharmacological, behavioral, psychosocial, environmental, or a combination of these approaches. Investigators primarily interested in another physical disorder outcome or investigators interested in treating a mental disorder (i.e., depression) to improve adherence to a regimen for another physical disorder (i.e., heart disease or diabetes) should seek funding from the NIH Institute or Center focused on that particular physical disorder. Research on improving adherence to interventions aimed at mental disorders per se are supported by the NIMH through PA-00-016, "Research on Adherence to Interventions for Mental Disorders" at http://grants.nih.gov/grants/guide/pa-files/PA-00-016.html. RESEARCH OBJECTIVES SUMMARY The NIMH encourages studies on the co-occurrence and co-morbidity of mental disorders with other physical disorders. An important goal of this program announcement is to identify potent, modifiable risk and protective factors amenable to intervention, and to translate the results of such studies into initial tests of theory-driven prevention and early intervention strategies. Risk and protective factors include biological, psychosocial, behavioral, and environmental contributors to co-morbid disorders. The program announcement encourages research on the efficacy, effectiveness, long-term outcome and safety of preventive, treatment, and rehabilitative interventions across the lifespan, clinical trials and intervention studies targeting functional and symptomatic outcomes adapting pharmacological, psychosocial, behavioral, or environmental approaches individually or in combination, studies to improve the recruitment and retention of individuals with co-morbid disorders in real- world practice settings, and research on the impact of separate organizational systems and different financing mechanism for mental and other physical disorders. Major emphasis is placed on the identification of principles motivating and sustaining behavior changes critical to reducing the risk for co-occurring disorders. Studies are particularly encouraged of mental disorders that are co-morbid with other physical disorders that are among the leading causes of morbidity and mortality in the United States, including heart disease, cancer, strokes, chronic obstructive pulmonary diseases, and diabetes, for example. The Institute will, however, consider applications that focus on any combination of co-morbid mental and other physical disorder across the lifespan, it is incumbent upon the applicant to demonstrate the public health significance of the study by describing the severity and/or prevalence of the disorders studied. Research applications solicited under this program announcement include, but are not limited to: o Studies of the incidence and prevalence of co-morbid mental and physical disorders/symptoms/related disability, especially epidemiological studies that elucidate potentially modifiable biological, behavioral, psychosocial, or environmental risk and protective processes o Investigations to discover potentially modifiable biological substrates that link co-morbid mental and other physical disorders, including research on neurotransmitters, neuropeptides, neuromodulators, hormones and other proteins, neural circuits, and neural systems (to include nervous, endocrine, and immune system pathways, e.g., the hypothalamic-pituitary-adrenal axis) o Proposals to discover potentially modifiable behavioral, psychosocial, or environmental risk and protective factors, including studies of motivation, decision-making, cognition, emotion, and social interactions between health care providers and consumers o Proposals to develop models of co-occurring mental and other physical disorders that specify the mediators and moderators responsible for translating risk into co-morbidity over time, or for protecting from risk over time o Tests of etiological models through experiments that probe the causal role of risk factors and presumed mediators and moderators of risk, including initial tests of innovative interventions. Interventions may be prevention, treatment, rehabilitation, pharmacological, behavioral, psychosocial, or environmental factors o Studies of stress where depression or anxiety disorders/symptoms are a central and explicit aspect of the conceptualization and measurement of "stress" o Studies to strengthen the diagnosis and assessment of co-morbid mental and physical disorders, including the development of new measures to improve reliability and validity, especially in real-world practice settings o Research on the kinds of individuals with co-morbid disorders seen in the general health care sector, especially primary care and emergency rooms, as well as on the types, quality, and effectiveness of mental health services delivered in that sector o Studies to clarify why and how the demands of treating other physical disorders interfere with care for mental disorders, especially in primary care settings o Examinations of the impact of treatment for another, secondary physical disorder on a primary or co-occurring mental disorder o Studies to determine whether people with mental disorders receive fewer medical services (e.g., cardiac assessments) for physical complaints, and, if so, why o Studies to determine whether health care costs for people with co-morbid mental and other physical disorders are greater than such costs among people with only one type of disorder, and to determine whether this is true even if those with co-morbid mental and other physical disorders receive fewer medical services (e.g., cardiac assessments) for physical complaints, and, if so, why o Investigations of the role of sub-clinical symptoms in the development and modulation of co-morbid disorders o Examinations of how treatments and services delivered in both the general and mental health sectors can be used to understand the needs and clinical characteristics of people with sub-syndromal conditions who also have other physical disorders o Studies using innovative methodologies (e.g., decision analysis) to examine and improve the clinical management of people with co-occurring mental and other physical disorders o Studies of referral patterns from the general health care sector to the mental health sector and barriers to referral for patients with co-occurring disorders rates, processes, and effect on patient outcomes, as well as strategies to overcome those barriers o Research on the impact of different reimbursement approaches on the use of general health vs. mental health services and implications for services, quality of care and outcomes of people with co-occurring disorders o Research on existing or innovative models linking or integrating mental health services with the general health sector especially for people with severe mental disorders and other co-occurring physical disorders o Studies of pain and co-morbid mental disorders o Examinations of self-management and behavior change strategies for co- morbid mental and other physical disorders across the lifespan o Studies to elucidate risk and protective processes associated with co- morbid mental and other physical disorders in those with chronic conditions that start as early development problems (e.g., mental retardation and autism) or chronic, late life problems such as dementia or infirmity o Studies to examine which of these risk and protective processes might be modified through preventive and treatment interventions, and how they might be most feasibly modified to prevent or alleviate co-morbid mental and other physical disorders o Studies of co-morbid mental and other physical disorders at the end of life MECHANISM OF SUPPORT This PA will use the NIH Small Grant (R03), Exploratory/Developmental Grant (R21), and Research Project Grant (R01) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The Small Grant (R03) provides up to two years of funding with a maximum of $50,000 direct costs for each year. The Exploratory/ Developmental Grant (R21) provides up to three years of funding with a maximum of $100,000 direct costs for each year, it is intended for pilot testing of interventions and other aspects of intervention development. Should funding levels for these grant mechanisms increase subsequent to the release of this program announcement, applicants may apply for the higher levels. The Research Project Grant (R01) provides up to five years of funding that is commensurate with the science proposed. Applications are encouraged under this announcement to develop and initially test innovative interventions. The Exploratory/Developmental Grant for Mental Health Interventions (R21) is the appropriate grant mechanism for this work. Because such research is by definition exploratory and developmental, extensive preliminary data or studies are not expected for R21 applications. For details, please see http://grants.nih.gov/grants/guide/pa-files/PA-99-134.html. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. Potential applicants are also encouraged to study co-morbid mental and other physical disorders by applying for Career Development Awards (the K Awards), which primarily provide salary support for full-time research. Program announcements describing in detail the various Career Development Awards may be found at http://www.nimh.nih.gov/grants/career.htm. Potential applicants interested in other award mechanisms are strongly encouraged to consult with program staff listed under INQUIRIES. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Peter Muehrer, Ph.D. Co-Morbidity Research Program Health and Behavioral Science Research Branch Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6189, MSC 9615 Bethesda, MD 20892-9615 Telephone: 301/443-4708 FAX: 301/480-2920 Email: pmuehrer@mail.nih.gov Junius J. Gonzales, M.D. Services Research and Clinical Epidemiology Branch Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7146, MSC 9631 Bethesda, MD 20892-9631 Telephone: 301/443-3364 FAX: 301/443-4045 Email: jgonzale@mail.nih.gov Debra J. Babcock, Ph.D., M.D. Division of Neuroscience & Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7178, MSC 9639 Bethesda, MD 20892-9639 Rockville, MD 20852 (FedEx, UPS, etc.) Telephone: 301/443-1692 FAX: 301/402-4740 Email: dbabcock@mail.nih.gov o Direct your questions about financial or grants management matters to: Diana S. Trunnell Grants Management Branch Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: 301/443-2805 FAX: 301/443-6885 Email: Diana_Trunnell@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study, 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award, and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed 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) APPLICATION PROCESSING: Applications must be received by or mailed before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The goals of 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the requested budget and the requested period of support as it relates to the proposed research. OTHER REVIEW CRITERIA: Additional considerations pertinent to the review of NIMH Small Grant (R03) applications: o Because the research plan is limited to 10 pages, a Small Grant application may not have the same level of detail or extensive discussion normally found in an R01 application. Review emphasis should be placed on conceptual framework and general approach to the problem, with less emphasis on methodological details. o Pilot/feasibility studies contain little or no preliminary data. Review should focus on whether the rationale for the study is well developed and whether the proposed research is likely to generate data that will lead to a regular research project grant or full-scale clinical trial. Adequate justification for the proposed work may be provided through literature citations, data from other sources, or investigator-generated data. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA (PA) in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLS IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH) and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of. 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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