This Program Announcement expires on December 31, 2003, unless reissued. PRESCRIPTION DRUG ABUSE Release Date: February 12, 2001 PA NUMBER: PA-01-048 (superseded by PA-04-110) National Institute on Drug Abuse ( THIS PROGRAM ANNOUNCEMENT (PA) USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE This PA encourages research aimed at reducing prescription drug abuse while supporting appropriate medical use of therapeutic agents with abuse liability. To promote the Nation’s health, research is needed to understand the factors contributing to prescription drug abuse, to characterize the adverse medical and social consequences associated with this abuse, and to develop effective prevention and service delivery approaches and behavioral and pharmacological treatments. Applications to address this issue are encouraged across a broad range of experimental approaches including basic, clinical, and epidemiological studies. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project (R01), small grant (R03), and exploratory/developmental grant (R21) award mechanisms. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will vary also. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Applicants are advised to contact NIDA program staff listed under INQUIRIES for additional information. Refer to the announcement for the specific eligibility requirements for the small grant (R03) at and the developmental/exploratory grant (R21) at Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated the size of an award will also vary. Awards under the R01 mechanism may not exceed 5 years. Awards under the R03 mechanism are limited to 2 years, and R21 awards are limited to 3 years. Modular budgeting procedures apply for grants up to $250,000. See for further information about modular budgets. RESEARCH OBJECTIVES Background Prescription drug abuse is on the rise (1999 National Household Survey on Drug Abuse). In 1999, 3.5% of 18-25 year olds reported past month nonmedical use of any psychotropic medication compared to 1.6% in 1994. An estimated 1.6 million Americans used prescription pain relievers nonmedically for the first time in 1998. This represents a significant increase in new users since the 1980s, when there were generally fewer than 500,000 initiates per year. Between 1990 and 1998, increases in new users of prescription pain relievers were reported in youths age 12-17, as well as in young adults age 18-25. In addition, concerns have been raised about increasing substance abuse among older adults (age 60 and older) and the potential impact of the aging of the baby boom generation on this problem. Alcohol and prescription drug misuse may affect as many as 17% of older adults [Substance Abuse Among Older Adults, SAMHSA/CSAT Treatment Improvement Protocol (TIP) Series 26]. Yet, proper treatment of many medical conditions requires the use of medications that can be misused, abused, and or lead to dependency. Applications are sought to define the extent of the problem of prescription drug abuse to characterize the issue in terms of class of drug abused, etiology of abuse, and populations most affected. Studies are needed on all classes of prescription drugs with abuse liability, including analgesics, stimulants, sedative/hypnotics/anxiolytics, and muscle building/performance enhancing drugs such as anabolic steroids. Researchers are encouraged to study the relationship between the prescription medication, the indication for which the medication was prescribed (e.g., pain, sleep disorder, anxiety disorder), and the environmental and individual factors contributing to abuse. Studies are also needed on the factors leading to diversion of prescription drugs into channels of illicit drug distribution and on measures to lessen this diversion, such as science-based education of health professionals. Research is needed to describe the populations most at risk for abuse of particular classes of drugs (including demographic factors and reasons for use), the source(s) of these drugs, and the consequences of drug use (e.g., adverse health outcomes such as drug overdose and drug interactions and behavioral and social consequences such as absenteeism and accidents). To reduce prescription drug abuse, research is needed on prevention approaches, service delivery, and behavioral and pharmacological treatments targeted to particular populations (e.g. the elderly, health professionals, and those with comorbid substance abuse and mental health disorders). Clinical studies are needed that take into account the patient’s age, gender, race/ethnicity, medical and psychiatric diagnoses, and current symtomatology and past and present treatments, as well as the clinical appropriateness or inappropriateness of prescribing practices. Surveys are also necessary to determine how attitudes, knowledge, and patterns of prescribing vary across categories of patients and health care providers and how these contribute to inappropriate prescribing practices and disparities in health care. For example, pharmacies may not stock opioid pain medications in racial and ethnic minority communities or low income communities, and there may be disparities in physicians prescribing practices to minority and low socio- economic status (SES) patients. Conversely, women are much more likely than men to be prescribed abusable prescription drugs, and prescription drug misuse/abuse among older women is a serious problem that has received little attention and often goes unrecognized by health professionals (CASA Report, June 1998). In general, prescription drug abuse in older adults begins with misuse due to inappropriate prescribing or lack of patient compliance with medication regimens. Continued misuse may progress to dependence. Older adults may be more vulnerable to prescription drug abuse because of age-related physiological changes that may influence the metabolism and response to prescription drugs, greater likelihood of having undiagnosed psychiatric and medical comorbidities, and difficulties in compliance with complex multiple drug regimens that may increase the likelihood of drug interactions. For example, benzodiazepines are frequently prescribed to older adults, but age related changes in drug metabolism, interactions with other prescription and over-the-counter medications, and use of alcohol may lead to increased use/misuse/abuse and adverse consequences such as impaired functional capacity and cognition. Yet, older Americans, their families, and their health care and service providers are frequently uninformed about the potential problems with psychoactive prescription drugs and, therefore, do not recognize these problems when they occur. The aging of the baby boom cohort may enhance the occurrence of substance abuse, including prescription drug abuse among older Americans because of this cohort’s prior use and abuse of psychoactive compounds. There is a need for research to develop screening, assessment, and diagnostic instruments (especially for use by health professionals in primary care settings) and prevention and treatment approaches targeted to prescription drug misuse and abuse in older adults. The increased use of prescription drugs among high school and college age youth is also of great concern. Young people frequently mix prescription drugs with other drugs of abuse, such as marijuana and alcohol, putting them at risk for drug interactions and overdose. When 12th graders were queried about use of specific amphetamines, methylphenidate use was widely reported; its use increased from 1992 (0.1%) to 1997 (2.8%) before leveling off (Monitoring the Future, Secondary School Students, 1999). Prescription of methylphenidate and other stimulants to treat attention-deficit hyperactivity disorder (ADHD) has increased in recent years. Studies are needed on the extent of misuse and abuse of those prescribed stimulant medications and on the extent to which youth prescribed these stimulants may provide these drugs to their peers. In addition, some health professionals (doctors, nurses, dentists, veterinarians, etc.) may be at risk because of their ready access to prescription drugs with abuse liability. Research is needed to identify the components of effective prevention and treatment approaches targeted toward health professionals. Program Description A range of research is needed to combat prescription drug abuse--from specifying the extent and nature of the problem (including health and social consequences) and identifying their determinants, to discovering effective clinical practices that identify those at risk and designing and disseminating prevention and treatment interventions. Research on addiction risk factors associated with the chronic therapeutic use of analgesics, stimulants, and sedative-hypnotics for psychiatric and other medical illnesses is needed. Studies that assess the risk of abuse or addiction to prescribed psychoactive medications for known therapeutic indications in patients with a history of polydrug abuse are also encouraged. Improved means of identifying who is at high risk of abusing or becoming addicted to prescribed psychoactive medications are needed to develop more effective prevention and treatment approaches. Basic, epidemiological, and clinical research is needed to identify interactions between abused prescription drugs and other abused drugs and alcohol. Areas of research interest include, but are not limited to, the following: Epidemiological, Prevention, and Clinical Research o Studies to evaluate whether non-compliance with prescription drug dosing regimens leads to sensitization that then increases the likelihood of transition from misuse to abuse. o Studies to evaluate the role of treatment with prescription drugs (for conditions such as sleep disorders, pain, etc.) in relapse to drug abuse. o Studies, by class of drug, on the nature and magnitude of prescription drug diversion from both licit and illicit sources. o Studies to identify patient populations who are under- or overmedicated or have difficulty obtaining adequate treatment with controlled substances. Studies on prescribing practices and attitudes of physicians (by specialty area, including primary care physicians) toward prescribing medications with abuse liability to different patient populations (such as women, the elderly, racial or ethnic minorities, uninsured) and patients with current or past substance abuse problems. o Studies to identify and to design prevention interventions for those adolescents and college-age youth at increased risk for prescription drug misuse and abuse. Types of prescription misuse and abuse among youth include: 1) the mixing of prescription drugs with other drugs of abuse (e.g., marijuana, alcohol), which places them at risk for drug interactions and overdose; 2) misuse and abuse of prescribed stimulants and providing these drugs to their peers; 3) combining dextromethorphan (DXM), a drug commonly found in cough medicine, and ecstasy, which is found at rave parties; 4) use of stimulants on college campuses for appetite suppression, wakefulness, increased attention, and euphoria. o Studies to design prevention interventions for individuals who may be at increased risk for prescription misuse and abuse in the following populations: 1) individuals with illnesses, such as arthritis, back pain, cancer, insomnia, fatigue, obesity, anxiety, eating disorders, etc., who are prescribed abusable prescription drugs; 2) health care professionals; and 3) the elderly. o Research on the factors that influence temporal trends in misuse and abuse of prescription drugs and how these relate to changes in the health care system, prescriptive practices, and sources of prescription medications (local pharmacy, mail order, other) and on the training of health care providers regarding prescription of medications with abuse liability. o Studies of the factors that predispose an individual to place over- reliance on and misuse prescription and over-the-counter drugs (e.g., health beliefs and practices, health promotion behaviors, reliance on media, cultural practices). o Studies of the adverse behavioral and social consequences associated with prescription drug misuse, abuse, and dependence, such as impairment in driving, parenting, job performance, independent living for the elderly, etc. o Studies to determine incidence, prevalence, and underlying pathophysiology of medical and health consequences of prescription drug misuse and abuse. Of particular interest are studies in those with HIV/AIDS and other infectious diseases that are prevalent in drug abusers. The consequences may include developmental, psychiatric, metabolic (including nutritional), endocrine, pharmacokinetic/pharmacodynamic drug-drug interactions, or other physiological system effects caused by or associated with the misuse and abuse of prescription drugs. Basic Research Basic research to understand the neuropsychopharmacological basis of prescription drug abuse such as: o Research that compares the risk of addiction to prescribed medications as a function of whether the individual receiving the drug is or is not actually in need of this treatment. For example, is the risk of addiction to opioids lessened when pain is present? If having a particular illness lessens the potential of addiction, the mechanism of this protection needs to be examined. o Studies to examine behavioral cross sensitization and relapse. Would, for example, a prescription with a mild stimulant action cause relapse in a former cocaine or amphetamine addict? o Studies to determine if the feelings of well-being induced by certain steroids (e.g., prednisone) are due to a direct or indirect mechanism. Is the euphoria sufficient to maintain drug-seeking? Will these steroids stimulate relapse under conditions of psychomotor stimulant abstinence? Will they reduce the aversiveness of drug withdrawal in general? o Studies on the use of prescription drugs to self-medicate. For example, fluoxetine is used in the treatment of depression and obsessive-compulsive disorder (OCD), but it is being misused/abused to protect from the neurotoxic action of methamphetamine, ecstasy, and other "club drugs." Studies are needed to determine the degree of protection afforded by fluoxetine and/or compounds with similar action on the serotonin transport mechanisms. Similar studies are indicated for dopamine uptake inhibitors. Treatment and Services Research o Studies to develop and evaluate effective treatment approaches for the management of pain, anxiety, sleep disorders, etc., in substance abusing patients. o Research on effective treatments (behavioral, pharmacological, alternative or complementary therapies) for individuals who misuse/abuse or become dependent on prescribed analgesics, stimulants, anxiolytics, or sedative- hypnotics. o Research on effective detoxification strategies for various classes of prescribed drugs with abuse liability. o Studies to develop and evaluate behavioral and pharmacological treatment approaches that maintain abstinence from prescription drug abuse and prevent relapse. o Studies to develop and test age-appropriate, gender sensitive, and culturally relevant treatment approaches for prescription drug abusing women, adolescents, older adults, racial and ethnic minorities, and individuals with comorbid substance abuse and mental disorders. For example, studies are needed in women who misuse/abuse prescription drugs and have comorbid mental disorders, such as depression, anxiety disorders, postraumatic stress disorder, and eating disorders. o Studies to develop and evaluate behavioral treatments to improve medication adherence and prevent misuse of prescribed medications among substance abusing patients with comorbid medical illnesses or mental disorders. o Studies to improve the screening, assessment, and recognition of prescription drug misuse and abuse among patients being treated in health care settings for acute and chronic medical and/or psychiatric illnesses. o Studies of brief behavioral interventions for prescription drug misuse and abuse among patients seen in primary care settings. o Studies that evaluate the use of medications for new indications in the treatment of prescription drug abuse (e.g., buprenorphine for codeine abuse). o Studies to determine the factors that may affect access to treatment for prescription drug abuse and addiction, including treatment entry, readiness for treatment, retention in treatment, compliance with treatment, and treatment outcomes among prescription drug abusing women, adolescents, older adults, and racial/ethnic minorities. o Research on the organization, management, and financing of treatment for prescription drug abuse and addiction. Studies on how linkages to other relevant treatment services, such as medical and psychiatric services, may improve access and improve treatment outcomes. o Research to develop and evaluate effective strategies/approaches for disseminating science-based information on the recognition, prevention, and treatment of prescription drug abuse to health professionals and community- based health care providers. Research to determine the most effective approaches for enhancing utilization of science-based information and whether these approaches actually change practice behaviors. o Research in pharmacoeconomics to study optimum drug therapy and health outcomes utilizing quality-of-life assessment and outcomes research. Such studies would provide economic information to inform clinical prescribing decisions and allocation of healthcare resources. 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 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (; a complete copy of the updated Guidelines is available at The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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: Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning these policies. 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. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review the recommendations of the Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at under Funding or may be obtained by calling (301) 443-2755. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application; i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page (see for sample pages). At the top of the page, enter the total direct costs requested for each year. This is not a Form page. Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and their role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: - Complete the educational block at the top of the form page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years; and - List selected peer-reviewed publications with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The title and number of the PA must be typed on line 2 of the face page of the application form and the YES box must be marked. 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines and will be reviewed for completeness by the Center for Scientific Review. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance the understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (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 methods? 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include 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. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct programmatic inquiries to: Dorynne Czechowicz, M.D. Division of Treatment and Research Development National Institute on Drug Abuse 6001 Executive Boulevard, Room 4231, MSC 9551 Bethesda, Maryland 20892-9551 Telephone: (301) 443-2237 Fax: (301) 443-8674 e-mail: Direct inquiries regarding fiscal matters to: Jack Manischewitz, Ph.D. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, Maryland 20892-9541 Telephone: (301) 443-6710 Fax: (301) 594-6849 e-mail: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or 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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