ENHANCING HIV VACCINE EFFICACY IN HIGH-RISK DRUG USERS RELEASE DATE: January 6, 2003 RFA NUMBER: DA-03-002 National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) LETTER OF INTENT RECEIPT DATE: March 14, 2003 APPLICATION RECEIPT DATE: April 14, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA NIDA invites domestic and international research applications related to the determination of HIV vaccine efficacy in high-risk drug-using populations. In drug-using populations, full efficacy of HIV vaccine candidates, currently in development, will be achieved through vaccine trials evaluating the candidate vaccine in combination with intervention(s) for substance abuse and related comorbidities. The current initiative seeks to support clinical research to develop strategies for implementing promising HIV vaccine candidates in cohorts of individuals at high risk for HIV infection and who abuse drugs or who are at high risk to abuse drugs. Most exposure to HIV is through high-risk behaviors and, in a substantial proportion of cases, individuals who are at high risk for HIV infection will likely remain at high risk for decades. A successful preventive or therapeutic vaccine for HIV/AIDS will, therefore, have to induce long-lasting immune responses or be given as boosts on a regular basis. Further, few studies have assessed the impact of behavioral interventions and/or treatment interventions for substance abuse on HIV incidence. Deployment of a vaccine that has shown efficacy in clinical trials - in the absence of the concurrent intervention for high-risk activity - could result in a vaccine whose effectiveness proves lower than its efficacy. Thus, behavioral and/or treatment interventions for substance abuse need to be identified and tested in populations at high-risk for HIV infection and targeted for phase III vaccine trials. The purpose of this RFA is to determine the validity of novel approaches to address the prevention of HIV and related blood-borne and sexually transmitted infections; as well as, to establish and study cohorts of high- risk drug users in the context of the developing HIV vaccine. Well-designed, targeted counseling and other interventions, such as chemotherapy for drug abuse, are needed to be adaptable and responsive to changing patterns of drug use and increasing risk behaviors of individuals exposed to first generation HIV vaccines. It is important to assess the effectiveness, sustainability, and durability of HIV prevention interventions and treatment interventions for substance users/abusers in concert with cohort HIV vaccinations studies. The data generated from such studies would provide efficacious mass vaccination paradigms for high-risk drug users. RESEARCH OBJECTIVES Background AIDS was first recognized as a growing epidemic among injection drug users (IDUs) and their sexual partners in the early 1980s. While considerable scientific progress has been made since then in understanding, preventing, and treating the intertwined epidemics of drug abuse and HIV/AIDS, much remains unknown or poorly understood today. Emerging drugs of abuse, such as the club drugs ecstasy, GHB, ketamine, and methamphetamine, as well as more potent supplies of heroin, cocaine, and marijuana, are rapidly changing the profiles of populations at risk. In the United States, since the epidemic began, injection drug use has directly or indirectly accounted for approximately 36 percent of AIDS cases. Fifty-seven percent of all AIDS cases among women have been attributed to injection drug use or sex with partners who inject drugs. Racial and ethnic minority populations of both genders have been deeply affected by drug abuse, HIV/AIDS, and other infectious diseases in recent years, with new HIV infections continuing at an alarming rate in the U.S. and in other nations. Well-designed, targeted counseling and other interventions, such as chemotherapy for drug abuse, are needed to be adaptable and responsive to changing patterns of drug use and increasing risk behaviors of individuals exposed to first generation HIV vaccines. To date, over 60 phase I/II trials of 30 candidate vaccines for HIV/AIDS have been conducted worldwide. Most initial approaches focused on the HIV envelope protein, produced in insect, bacteria, yeast or mammalian cells, which was logical given that envelope is the primary target for neutralizing antibodies in HIV-infected persons. At least 13 different gp120 and gp160 envelope candidates have been evaluated in phase I/II trials, predominantly through a NIAID-supported AIDS Vaccine Evaluation Group. Overall, they have been safe and immunogenic in diverse populations that have excluded substance abusers. In these studies neutralizing antibodies have been induced in nearly 100 percent of the recipients, but rarely induced CD8+ cytotoxic T lymphocytes (CTL) even when formulated in novel adjuvants that effectively induced CTL in mice. Mammalian derived envelope preparations have been better inducers of neutralizing antibody than candidates produced in yeast and bacteria. The antibodies induced by these early envelope preparations were relatively specific for clade B isolates and rarely neutralized primary isolates of HIV. As low levels of neutralizing antibody titers in some circumstances may provide protection from viral infection, bivalent preparations of gp120, based on one lab (B) and one primary isolate (B or E) of HIV, have been developed and are now being tested in phase III trials in Thailand in a cohort of intravenous drug users. In an effort to induce both CTL and antibody responses, attention has also turned to evaluating a combination vaccine approach in which two types of vaccines are used. Most commonly referred to as "prime-boost", this has involved an immunization (priming) with a recombinant viral vector followed by or combined with boosting doses of recombinant protein. Three recombinant attenuated vaccinia vectors and five recombinant canarypox vectors have been evaluated in phase I trials, alone, and in combination with a recombinant protein envelope boost. To date, all recombinant viral vectors have been shown to be safe and immunogenic and have been shown to prime the immune response to an envelope boost, thereby necessitating fewer doses of recombinant protein to reach maximum antibodies titers. However, the antibodies elicited in prime-boost protocols so far have a limited breadth of reactivity. Full efficacy of these HIV vaccine candidates will be achieved through vaccine trials evaluating the candidate vaccine in combination with an intervention for substance abuse and high-risk sexual behavior among substance abusers. The current initiative seeks to support clinical research to develop strategies for implementing promising HIV vaccine candidates in cohorts of individuals at high risk for HIV infection and who abuse drugs. Areas of interest include but are not limited to: o Behavioral interventions that can be coupled to vaccine schedules that enhance vaccine efficacy and promote HIV prevention and/or STD prevention and treatment among distinct drug using population subgroups (e.g., IDUs, crack abusers, club drug abusers) o Drug treatment interventions that can be coupled to vaccine schedules that enhance vaccine efficacy and promote HIV prevention and/or STD prevention and treatment among distinct drug using population subgroups (e.g., IDUs, crack abusers, club drug abusers and polydrug abusers) o Assess the acceptability (i.e., identify factors that facilitate and hinder) of implementing vaccine trial schedules among distinct drug- using population subgroups (e.g., IDUs, crack abusers, club drug abusers and polydrug abusers) o Develop, implement, and evaluate community-based programs targeted to high- risk individuals that promote HIV vaccine acceptance o Longitudinal evaluation of substance users/abusers for surrogate immunological and/or genetic markers of HIV vaccine efficacy and modifications of immune responses due to drug abuse o Use of surrogate vaccines, such as hepatitis B vaccine, in high-risk substance users/abusers to study medical management issues including adherence, clinical setting and services related to substance abuse and its comorbidities, vaccination efficacy parameters, patient follow-up to vaccination schedule o Mathematical modeling of HIV vaccination in substance using/abusing populations o Develop and evaluate research methods strategies to efficiently estimate the combined and individual effects of the behavioral interventions and vaccine components on both behavioral outcomes and incidence rates of infection o Therapeutic HIV vaccination paradigms for substance abusers combining vaccination with antiretroviral therapy o Barriers to implementing HIV vaccination strategies for IDU populations and other disenfranchised individuals o Implementing vaccine protocols in high-risk adolescents o Ethical issues related to HIV vaccines and substance abusers o Investigations of comorbidities, e.g. hepatitis infection, psychiatric illness, in substance abusers that would influence the effectiveness of an HIV vaccine o Neurological aspects of HIV/AIDS, addiction and vaccination o Clearly defined basic research vaccination studies to understand the basic mechanisms where drug addiction processes may influence the immune response to the vaccine candidate. Drugs of interest include, but are not limited to, opiates, cannabinoids, cocaine and metamphetamine. MECHANISMS OF SUPPORT This RFA will use National Institutes of Health (NIH) investigator-initiated research project (R01), and the NIDA exploratory/developmental (R21) award mechanisms. NIDA's R21 grant is limited to 3 years with maximum direct cost amount per year of $100,000. The R21 mechanism is intended to encourage exploratory research projects with sound methodology and strong rationales in underdeveloped research areas of HIV prevention interventions for drug users, such as the areas covered in this RFA. Applicants are also advised to contact NIDA program staff listed under INQUIRIES for additional information. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 2003. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see https://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. FUNDS AVAILABLE NIDA intends to commit approximately $2,000,000 in FY 2003 to fund six to ten new awards in response to this RFA. Because the nature and scope of the research proposed may vary, it is anticipated that the number of awards and the size of each award will also vary. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIDA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. 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 or community-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 inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Thomas F. Kresina, Ph.D. Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA) National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 5200, MSC 9593 Bethesda, MD 20892-9593 Telephone: (301) 402-1913 Email: tk13v@nih.gov o Direct your questions about peer review matters to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-2755 Email: tlevitin@mail.nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3131 MSC 9541 Bethesda, Maryland 20892-9541 Telephone: (301) 443-6710 E-mail: gfleming@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Rockville, Maryland 20852 (for express/courier service) Telephone: (301) 443-2755 Fax: (301) 443-0538 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 https://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. 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 https://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 https://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health/DHHS 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: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Rockville, Maryland 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Council on Drug Abuse. 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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: o 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. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and 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) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 14,2003 Application Receipt Date: April 14, 2003 Peer Review Date: June/July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phases 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: https://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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see https://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html 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 these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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. Furthermore, we caution reviewers 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 RFA 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. 93.279, 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 https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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