ACUTE CORONARY SYNDROMES IN OLD AGE RELEASE DATE: November 21, 2003 PA NUMBER: PA-04-026 EXPIRATION DATE: December 1, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Aging (NIA) (http://www.nia.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.866 THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Funds Available 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 OF THIS PA The goal of this program is to foster biomedical research that will lead to a better understanding of the biology, pathophysiology, clinical presentation, and medical management of the acute coronary syndromes (ACS) in old age. This PA is intended to foster clinical research, including integrative biomedical research, some of which will incorporate the tools of molecular and cellular biology in the study of function and clinical outcome. A long-term goal is to provide the necessary framework for the development of effective prevention and/or new treatment strategies for ACS in old age. RESEARCH OBJECTIVES Background The acute coronary syndromes (ACS) are defined by a spectrum of clinical conditions ranging from unstable angina (coronary heart disease-related chest pain at rest), to non-Q wave and Q-wave acute myocardial infarction (i.e., heart attack). They are among the most common disorders seen in the emergency room and are often missed in many older patients who present with chest pain. It is estimated that there are over 1 million episodes of ACS per year in persons aged 65 years and older and that up to 33% of acute heart attacks are clinically unrecognized in the older population. In the U.S., persons aged 65 years and older account for more than 60% of acute heart attacks and for more than 80% of heart attack deaths (Society of Geriatric Cardiology). There has been a great deal of research on the ACS in the younger (i.e., less than 75 years of age) population. For example, in patients up to 75 years of age presenting with an acute heart attack (ST-segment elevation), thrombolytic therapy is associated with a significant reduction in mortality. Yet, the clinical benefits of this important therapy in patients aged 75 years and older remain to be defined. Moreover, early administration of angiotensin converting enzyme (ACE) inhibitors is beneficial in patients up to age 75 years. However, the importance of ACE inhibitors in the patient population aged greater than 75 years remains unanswered. Many clinical studies, including clinical trials, have excluded older patients, including the very elderly, and have also excluded older persons with significant co- morbidities. Past studies have also not focused on key issues that assume larger, sometimes primary, importance among older patients including health-related quality of life and end of life issues, personal preferences, depression, and co-morbidity. Available data suggest that elderly patients with the ACS have different clinical presentations, therapeutic responses, and natural histories than younger patients. A meta-analysis (Fibrinolytic Therapy Trialists Collaborative Group) has shown that elderly patients with the ACS, even with early and complete thrombolysis, have a higher mortality than younger patients. Moreover, despite recent treatment advances for the ACS, older patients still have a higher risk of morbidity, mortality, and complications following therapy. It appears that the prognosis is worse for older women (versus men) and older ethnic minorities (versus Caucasians). Older persons have complex atherosclerotic plaque and more severe coronary heart disease than younger persons. Thus, plaque stabilization to prevent the risk of rupture and thrombus formation remains an important research area. New research suggests the importance of inflammation in playing a major role in plaque vulnerability to rupture and thrombus formation. Development and testing of new therapies targeting the inflammatory component of the ACS is an important and active area of investigation. Data have also accumulated suggesting a limited tolerance to even short term ischemia in older persons that leads to early cell death (apoptosis), altered cardiac energetics and calcium handling, and a limited recovery of ventricular function following successful reperfusion therapy. Animal studies suggest the importance of an age- related impairment in angiogenesis in the response to ischemia. Research on the early response of the heart to ischemic injury remains an important area of research. In light of the anticipated rise in the number of older persons who will develop cardiovascular disease over the next several decades, there is a compelling need now to expand basic and clinical research (including translational research) into the pathophysiologic mechanisms, clinical manifestations, treatment, and prevention of the ACS in old age. Additional background information on the epidemiology, pathophysiology, biologic mechanisms, clinical features, therapy, and prognosis of the ACS in older adults is available in the summary of a recent conference Acute Coronary Syndromes in the Elderly: Mechanisms and Management, organized by the Society of Geriatric Cardiology with support provided by the NIA. A summary of research recommendations from this conference can be accessed at http://www.sgcard.org/conferences/price%202/PRICE-II.Final%20research%20recommendations.rev.pdf The Executive Summary of the conference has been published in the American Journal of Geriatric Cardiology (Rich, MW for the PRICE-II Organizing Committee and PRICE-II Investigators. Second Pivotal Research in Cardiovascular Syndromes in the Elderly (PRICE-II) Symposium Acute Coronary Syndromes in the Elderly: Mechanisms and Management. Am. J. Geriatr. Cardiol. 2003; 12:307-318, 327). Knowledge to be Achieved This PA solicits proposals for research to: 1. Clarify age-related differences in risk, and for different clinical and cardiac functional ACS outcomes, responses to specific ACS interventions, and post-acute sequellae, and the causes of these differences. Attention to outcomes (including subsequent disability and frailty) in the very old and in older patients with comorbid conditions is particularly encouraged. Both observational and intervention studies may be proposed. Studies that develop and apply methods to integrate information from observational studies and clinical trials to improve generalizability of research findings on this topic are also appropriate. 2. Identify determinants of good and poor short- and long-term outcomes among older ACS patients, and the mechanisms responsible for these outcomes. In addition to risk factors, the identification of protective factors that are associated with unusually good outcomes is of interest. Clinical factors of interest in regard to possible effects on outcomes in older adults with the ACS include, but are not limited to: delayed clinical presentation, specific co-morbid conditions, atypical symptoms upon presentation, severity of coronary heart disease, and risk factors for complications from drug and/or procedural interventions. Physiologic factors of interest include age-related changes in myocardial responses to ischemia, and changes in other systems that may affect survival or severity of morbidity. 3. Identify and characterize aging changes and age-related conditions that contribute to poor ACS outcomes in older persons; and elucidate the mechanisms that cause or modulate changes with important effects on ACS outcomes in old age. Examples of aging changes whose effects on ACS outcomes could be explored include, but are not limited to: o Age-related changes in cardiovascular properties and functions such as: vascular and ventricular compliance, diastolic filling, endothelial function, beta-adrenergic responsiveness, responses to ischemic preconditioning, mitochondrial function, calcium homeostasis, cardiac myocyte apoptosis, myocardial microvasculature, myocardial angiogenic responses to ischemia, plaque morphology and stability, extracellular matrix and remodeling, and the pulmonary vasculature. The use of innovative, non-invasive, imaging techniques (e.g., high resolution MRI) is highly desirable; o Age-related changes in hemostatic and fibrinolytic systems; o Age-related changes in inflammatory responses to stimuli such as endothelial injury in regard to ACS related outcomes such as risk of atherosclerotic plaque rupture, thrombus formation, and adverse clinical outcomes (including death) in older adults; Studies on the effects of specific comorbid conditions (e.g., diabetes) on ACS outcomes in older persons, and the mechanisms responsible for these effects are encouraged. Studies on the role of age-related pathophysiologic interactions between different physiologic systems (e.g., interactions of inflammation and vascular stiffness) in adverse ACS outcomes are also of interest. 4. Determine effects on ACS outcomes in older patients (or aging animal models of ACS) of interventions that could reverse, or counter the effects, of aging changes (e.g., in cardiovascular properties, hemostasis, fibrinolysis, or inflammation) that contribute to poorer outcomes in older ACS patients. Attention to outcomes in the very old and in older persons with comorbid conditions is strongly encouraged. Both pharmacologic and lifestyle interventions (e.g., physical activity and weight loss) are of interest. 5. Develop and validate novel ACS animal models that mimic the human condition in old age. 6. Determine the clinical features, responses to treatments, and prognoses of elderly women and elderly ethnic minorities with the ACS who tend to have more prevalent disease than men and non-ethnic minorities, respectively. Studies should determine the pathophysiologic mechanisms underlying the observed differences in the clinical presentations and outcomes in these vulnerable populations. In all the above areas, an integrative approach to the ACS, through collaboration between basic and clinical scientists, is highly desirable. These topics are neither prioritized nor meant to be restrictive. Investigators are encouraged to submit applications in any area of research addressing the general research objectives of the PA. MECHANISM OF SUPPORT This PA will use the NIH research project grant (R01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this PA may not exceed five years. 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. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm FUNDS AVAILABLE NIA intends to commit $1.5 million in total costs for funding of meritorious applications submitted in response to this PA over the three year duration of the PA. Awards made will be contingent upon availability of these funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. Applications will also compete for funding with all other applications assigned to the NIA. ELIGIBLE INSTITUTIONS You may submit an application 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 institutions/organizations 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 his or her 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 to 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: Andre J. Premen, Ph.D. Geriatrics & Clinical Gerontology Program National Institute on Aging Gateway Building, Room 3C-307 Bethesda, MD 20892-9205 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: PremenA@nia.nih.gov o Direct your questions about financial or grants management matters to: Ms. Linda Whipp Grants Management Officer Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: WhippL@nia.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. 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 The title and number of this PA must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this PA 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 the 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 member 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 member 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 mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The Center for Scientific Review (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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups 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 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 written critique 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 evaluate applications in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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. 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? 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? 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? 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)? 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, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN AND MINORITIES IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. Additional information can be found at http://grants.nih.gov/grants/policy/data_sharing BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. 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 HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I), efficacy studies (phase II), and efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (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. SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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 "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 is 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. 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 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/ AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and to 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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