BIOLOGY OF ADULT STEM CELLS IN AGING Release Date: June 6, 2001 RFA: RFA-AG-01-006 National Institute on Aging (http://www.nih.gov/nia/) Letter of Intent Receipt Date: August 14, 2001 Application Receipt Date: September 11, 2001 THIS RFA 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 RFA. PURPOSE This Request for Applications (RFA) is to solicit applications that address the basic biology of adult stem cells in aging. Research to elucidate the changes that take place in stem cells and their environment with normal age and age-related disease will be crucial to understanding how and why tissues, organs and organisms senesce and to eventual development of stem cell based therapies for the aged. Projects are encouraged that significantly advance research to identify and characterize adult stem cells as a function of aging, characterize the tissue environment and the interaction of adult stem cells with that environment during aging, separate, monitor and control adult stem cells from and in aging tissue, and develop or use disease models to understand the biology of adult stem cells in disease states common to aged individuals. Applications are solicited for research projects that focus on various aging tissues or physiological systems, including cardiovascular, musculoskeletal, immune, urogenital, endocrine and nervous systems. 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 Request for Applications (RFA), Stem Cells in Aging, 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/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. Only new (Type 1) applications will be accepted for this initiative. Responsibility for the planning, direction and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to the present RFA may not exceed five years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The earliest anticipated award date is April 1, 2002 Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at: http://grants.nih.gov/grants/funding/modular/modular.htm FUNDS AVAILABLE The NIA has set aside $2 Million for the first year of support for grants awarded in response to this RFA. Maximum direct costs requested may not exceed $250,000 for the first year. It is anticipated that 5 to 7 R01 grants will be supported. Awards are contingent upon availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. Applications that are not funded may be revised and resubmitted under regular grant procedures for the NIH. Direct costs will be awarded in modules of $25,000, less any overlap or other necessary administrative adjustments. Facilities and Administrative costs will be awarded at the negotiated rate. RESEARCH OBJECTIVES Background Stem cells have been derived from both adult and embryonic tissues in the mouse. Mouse embryonic stem cells have the capacity to differentiate into all cell types in the body when incorporated into the early embryo. When injected under the skin of the adult mouse, they form tumors that contain many differentiated cell types. Stem cells in adult humans may hold the potential to form needed cell types in cases where disease or injury have destroyed the original cells. However, human embryonic stem cells have only recently been cultured, and whether they are analogous to mouse embryonic stem cells in potential to form tissues or tumors is still unknown. Furthermore, research on how to control even mouse embryonic stem cells to form desired, functional cell types in the desired locations in the body has produced limited results. Successes in this area include the triggering of partial differentiation in culture of mouse embryonic stem cells to a pre-differentiated state and injection of those cells into areas of injury with partial recovery of function. Similar work is continuing on a number of fronts including in spinal cord, cardiac tissue and brain tissue. For many years, it has been clear that putative stem cells (cells that can divide to replenish themselves and, as well, produce daughter cells that transition into differentiated cell types) exist in a number of adult tissues, including bone marrow, muscle, and intestine. For example, the crypt cells of the small intestine form cells that renew the lining of the intestine as cells are lost from the villi. Bone marrow cells have been used to replace the hematopoietic and immune systems in therapies for diseases. Overturning long held beliefs, the adult brain has now been shown to harbor putative stem cells that can generate all neural cell types. In recent years, it has become evident that, at least in the mouse, adult tissue-derived stem cells, when manipulated or grafted into appropriate environments, can form more than the cell types of the tissue of origin. Recent examples include cells from bone marrow that can integrate into skeletal myofibers, form oval cells of the liver (and hepatocytes upon liver injury), glial cells of the central nervous system, and neuron-like cells in the central nervous system. Selected hematopietic stem cells can form cardiomyocytes that replace damaged cells in the mouse heart. Conversely, muscle-derived stem cells can replenish the hematopoietic compartment and nervous system stem cells can form blood elements and skeletal muscle cells. Because mouse adult tissue-derived stem cells appear to be able to differentiate more broadly than at first thought, adult stem cells present some of the same possibilities for tissue-replacement therapy as embryonic stem cells, and some of the same challenges. In addition, if the rules by which comparable human adult stem cells divide and differentiate can be understood, there are some advantages for use of these cells. For example, it might be possible to use bone marrow- derived cells to provide a source of graft material to replace brain cells lost through disease or injury. Indeed, depending on the circumstances of the disease, it may be possible to use a patient’s own cells for such a therapy, avoiding immune obstacles to grafting in humans. There is further promise in understanding the natural role of stem cells in tissues of the adult. Investigation into changes in stem cell biology with age may lead to better understanding of the fundamental properties of stem cells and the rules by which they function in vivo. For example, in humans a number of tissues undergo changes that are detrimental to the health and quality of life of aging individuals. Muscles, which have a supply of stem cells for addition of muscle mass or replacement of muscle fibers, still undergo loss of muscle mass, changes in fiber types, and other changes that lead to muscle weakness in the elderly. Bone may become weak and brittle due to changes in turnover and remodeling rates. These changes may be due to an altered balance between different bone cell types derived from marrow precursors. Certain areas of the adult brain retain the capacity to generate new neurons and glia, yet neuronal dysfunction and decrement in brain function can occur with aging. It is unclear whether such changes could be due in part to diminishing supply of stem cells with age, altered potential of stem cells to form the required cell types to keep a tissue healthy with age, altered aging tissue environments that restrict the growth, migration or differentiation of the resident stem cells, or other factors associated with age. Emerging findings suggest that tissue stem cells can be coaxed into forming new differentiated cells of an organ through environmental manipulations as, for example, in enhanced numbers of new hippocampal neurons in adult mice. Finally, investigation into the changing properties of adult stem cells with age is likely to provide clues to aging itself. It is possible that resident tissue stem cells are susceptible to damage mechanisms thought to cause senescence at the cell and tissue levels. Changes in the supply and potential of adult stem cells for replacement of cells in the course of normal tissue turnover may be fundamental to the aging of the organism. Thus, not only is investigation of stem cell biology in the aging environment crucial to understanding of diseases of aging, to development of therapies that allow better quality of life for aging individuals, for understanding normal cell turnover in tissues, and for future possible replacement of diseased or damaged tissue in the elderly, but such investigations may also be pivotal in the study of how and why organisms senesce. Objectives and Scope This RFA is intended to promote the exploration of changes in adult stem cell biology with aging. Only applications for projects focused on understanding stem cell biology during aging, understanding the aging environment and its influence on stem cell biology, and understanding stem cell biology in disease states common to aged individuals, and with a clear relationship to aging as a major emphasis, will be accepted for review. Research projects that focus on various aging cells, tissues or physiological systems, including cardiovascular, musculoskeletal, immune, urogenital, endocrine and nervous systems are of interest, as are studies that use animal models or adult human tissue. Because of the focus of this RFA on basic biology of aging stem cells, clinical studies in humans are outside the scope of this RFA, as are studies on human embryonic stem cells. However, under certain circumstances, projects that involve embryonic stem cells from animal models to explore aging stem cells and the aging environment may be appropriate. Applicants are encouraged to discuss such projects with NIA program staff before submission. The following areas are of special interest but are examples only, and are not exclusive. o Investigation of the numbers and types of stem cells resident in tissues of the adult and how those populations of stem cells change during aging. o Characterization of the natural potential for growth, self-renewal, migration and differentiation of adult stem cells and their progeny in vivo as a function of aging. o Manipulation and control of the potential for growth, self-renewal, migration and differentiation in vivo and in vitro for adult stem cells and their progeny from aging animals/humans. o Investigation of changes in aging tissue environments and the effects of those changes on stem cell function and on differentiation of stem cell progeny. o Methods to identify, separate, isolate and monitor stem cells in aging tissues. o Investigation of disease models and function of adult stem cells in disease states common to aged individuals. o Characterization of the ability of transplanted or resident adult stem cells or their progeny to integrate with host tissue of different ages to produce functional changes or restore impaired tissue function. o Characterization of genetic determinants influencing adult stem cell function in aging and age-related disorders. o Investigation of the interrelationship between stem cells and fundamental processes that determine the rate at which organisms age. SPECIAL REQUIREMENTS Applicants are encouraged to talk directly to program staff about research allowed under this RFA prior to formulating the application. Sharing of Research Resources Restricted availability of unique research resources, upon which further studies are dependent, can impede the advancement of research. The NIH is interested in ensuring that the research resources developed through grants become readily available to the broader research community in a timely manner for further research, development, and application, in the expectation that this will lead to products and knowledge of benefit to the public health. It is expected that resources to be shared will include, among others, cell lines, mutant animals, germplasm, and novel reagents and techniques. Plans Applicants who respond to this RFA must submit a plan: (1) for sharing research resources generated through the grant, and (2) addressing how they will exercise intellectual property rights, should any be generated through this grant, while making such research resources available to the broader scientific community. The sharing of research resources plan and intellectual property plan must describe how unique research resources will be made readily available for research purposes to qualified individuals within the scientific community in accordance with the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/ and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 http://www.ott.nih.gov/policy/rt_guide_final.html and http://ott.od.nih.gov/NewPages/64FR72090.pdf These documents also define terms, parties and responsibilities, prescribe the order of disposition of rights, prescribe a chronology of reporting requirements, and delineate the basis for and extent of government actions to retain rights. Patent rights clauses may be found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page, http://www.iedison.gov. Applicants are encouraged to discuss the plans with their Institutional Official and office for technology transfer prior to submission of the application. The applicant organization signature on the application indicates the agreement of the organization with the plan in the application. Annual Grantee Meeting It is the intent of the NIA to provide support for stem cell research through grant support and through promoting collaboration and information sharing between investigators on projects of interest to the NIA. Principal Investigators (PI) on grants resulting from this RFA must participate in annual workshops convened by the NIA for updates and exchange of information related to the projects between investigators and with NIA staff. In the event the PI is unable to attend, a mutually acceptable designee may be agreed upon by the grantee and NIA staff to participate. Travel to this annual workshop, expected to be in Bethesda, MD should be included in the budget request in the application. 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 are 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: 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. In addition, applicants should pay particular attention to inclusion of appropriate information as instructed for the PHS 398 form in any application involving human subjects. 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. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 IC staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to the program staff listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. These forms are available at most institutional offices of sponsored research, 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: grantsinfo@nih.gov, and on the internet at: http://grants.nih.gov/grants/funding/phs398/phs398.html. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note that this sample label is in pdf format. Applications should be complete at the time of submission. The Scientific Review Office, NIA, will determine whether late materials will be accepted. If late materials are accepted, they will be limited to three typed pages and the Scientific Review Administrator in charge of the review must authorize submission. 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. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules. 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 $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 http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o 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 the 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 key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - 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, - 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. o 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. Submit a signed, typewritten original of the application and three 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) At the time of submission, send two additional copies of the application to: Mary Nekola, Ph.D. Chief, Scientific Review Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Room 2C212 Bethesda, MD 20892-9205 It is important to send these copies at the same time as the original and three copies are sent to the Center for Scientific Review. These copies are used to identify conflicts and to help ensure the appropriate and timely review of the application. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIA. Incomplete applications will be returned to the applicant. If the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. 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 NIA in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council on Aging. 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 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 method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 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 as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 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. Reviewers will comment, as appropriate, on the adequacy and feasibility of the sharing of research resources plan and the intellectual property plan. Comments on the plans and any concerns will be presented in an administrative note in the Summary Statement. NIH program staff will consider the adequacy of the plans in determining whether to recommend an application for award. The approved plans will become a condition of the grant award and Progress Reports must contain information on activities for the sharing of research resources and intellectual property. The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. Schedule: Letter of Intent Receipt Date: August 14, 2001 Application Receipt Date: September 11, 2001 Date of Initial Review: December, 2001 Review by Advisory Council: February, 2002 Anticipated Award Date: April 1, 2002 AWARD CRITERIA The following will be considered in making funding decisions: o Scientific merit as determined by peer review o Availability of funds o Programmatic priorities o Adequacy of plan for sharing of research resources and plan for intellectual property INQUIRIES Inquiries concerning this RFA are encouraged. Additional information, including sample budget narratives and biographical sketch, may be found at this site: http://grants.nih.gov/grants/funding/modular/modular.htm. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jill L. Carrington, Ph.D. Chief, Systems Branch Biology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 2C231 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: jc189n@nih.gov Bradley C. Wise, Ph.D. Program Director, Fundamental Neuroscience Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3C307 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: bw86y@nih.gov Direct inquiries regarding fiscal matters to: Ms Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: lw17m@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. 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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