RFA-DK-02-016: SURROGATE ENDPOINTS FOR DIABETIC MICROVASCULAR COMPLICATIONS

Department of Health
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SURROGATE ENDPOINTS FOR DIABETIC MICROVASCULAR COMPLICATIONS Release Date: August 30, 2001 RFA: RFA-DK 02-016 National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) National Eye Institute (http://www.nei.nih.gov) National Institute of Neurological Disorders and Stroke (http://www.ninds.nih.gov) Letter of Intent Receipt Date: January 17, 2002 Application Receipt Date: February 14, 2002 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Eye Institute (NEI) and the National Institute of Neurological Disorders and Stroke (NINDS) seek applications to develop and validate biomarkers for the microvascular complications of diabetes. Prevention and treatment of long-term micro- and macrovascular complications remain a critical problem in the management of type 1 and type 2 diabetes mellitus. In the United States, diabetes is the leading cause of new blindness in working-age adults, of new cases of end stage renal disease and of non-traumatic lower leg amputations. Basic science advances in the coming years are expected to lead to new therapies to prevent or treat the development of nephropathy, retinopathy and neuropathy. Surrogate endpoints for complications can be utilized in clinical trials to assess the efficacy of these new therapies. In addition, such biomarkers may be useful for predicting those patients who are at high risk for the development of complications, and who may benefit from aggressive intervention. This RFA invites basic and clinical research applications to develop biochemical, cellular, physiologic or genetic surrogate endpoints that can be used to predict risk, aid in early diagnosis and assess progression of the microvascular complications of diabetes. 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, Surrogate Markers for Diabetic Microvascular Complications, is related to the priority area of diabetes and chronic disabling conditions. 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 nonprofit 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) and the Exploratory/Development Research Grant (R21) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an R01 application submitted in response to this RFA may not exceed 5 years. Applications with requested budgets up to $250,000 direct costs in any year must use the modular grants format. Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions. The R21 awards are to demonstrate feasibility and to obtain preliminary data testing innovative ideas that represent clear departure from ongoing research interests. These grants are intended to 1) provide initial support for new investigators, 2) allow exploration of possible innovative new directions for established investigators, and 3) stimulate investigators from other areas to lend their expertise to research within the scope of this solicitation. Applicants for the R21 must limit their requests to $125,000 direct costs per year and are limited to two years. These R21 grants will not be renewable, continuation of projects developed under this program will be through the regular research grant (R01) program. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm FUNDS AVAILABLE For fiscal year 2002, the NIDDK, the NEI and the NINDS intend to commit approximately $2 million to fund 4 to 10 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 5 years for R01s and up to two years for R21s. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIDDK, the NEI and the NINDS 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 applications of outstanding scientific and technical merit. At this time, it is not known if this RFA will be reissued. RESEARCH OBJECTIVES Background Prevention and treatment of long-term complications remain a critical problem in the management of type 1 and type 2 diabetes mellitus. In the United States, diabetes is the leading cause of new blindness in working-age adults, of new cases of end stage renal disease and of non-traumatic lower leg amputations. Diabetes has been estimated to cost the United States economy over $98 billion annually, much of this cost is related to the treatment of the long-term micro- and macrovascular complications of diabetes. Identification of patients at risk for the development of complications, with the hope of early intervention, is a public health priority. Early intervention is essential, because, by the time symptoms of disease are recognized, irreparable structural organ damage may have already occurred. Diabetic nephropathy is the most common cause of end-stage renal disease (ESRD) in the U.S., accounting for approximately 45% of new cases. Major risk factors for the development of diabetic nephropathy include duration of diabetes and poor metabolic control. However, there is considerable ethnic/racial variability in the incidence of nephropathy, and not all patients with prolonged hyperglycemia develop ESRD, suggesting a strong genetic component to susceptibility. For renal disease, a valuable biomarker exists microalbuminuria is the best available non-invasive predictor of diabetic nephropathy risk. Screening for microalbuminuria is considered standard of care and treatment of patients who have microalbuminuria with angiotensin converting enzyme inhibitors is partially effective in slowing progression to overt proteinuria and renal disease. However, the predictive value of microalbuminuria for the progression to overt nephropathy is not precise. More data are needed to delineate the extent to which increases in microalbuminuria predict either pathological progression, or ultimate progression to end stage disease. In addition, some patients in whom microalbuminuria has not increased may nonetheless develop advanced renal lesions. Finally, prevention strategies might be most effective in patients with normal albumin excretion, if patients at high risk for the development of nephropathy could be identified before the development of microalbuminuria. Neuropathy is a frequent complication of diabetes. Symptoms include weakness, pain, and numbness, which may be serious enough to interfere with daily activities. To evaluate symptoms of diabetic neuropathy, standardized checklists have been developed and scoring systems devised that take into account symptom frequency and intensity. This approach is not very reliable, and is of little use for early intervention because symptoms may not occur until after neurological damage has occurred. Nerve conduction studies have been used to diagnose peripheral neuropathy for decades, however, results vary by age and sex, and the reliability of the tests can be affected by location of electrodes, distances measured, and temperature. Sural nerve biopsies can provide a great deal of information, but the procedure is highly invasive. Information on the status of nerves in the skin can also be obtained from skin punch biopsies or from a recently described skin blister method, but these diagnostic techniques are also relatively invasive. Reduced sensation can be detected with a monofilament, however, symptoms may not develop until after considerable nerve damage has occurred. Diabetic peripheral neuropathy is often associated with peripheral vascular disease and impaired wound healing, resulting in more than 200,000 cases of foot ulcers and 80,000 amputations per year, with an annual medical cost of over $2 billion. In fact, diabetes is the leading cause of non-traumatic lower leg amputations in the United States. Thus, a top priority is the development of simple and reliable surrogate markers of early damage, to allow effective early intervention (i.e., before symptoms develop) to prevent ulcerations and disability. In addition, there are currently no widely accepted non-invasive surrogate markers that can be used to evaluate patient status, to measure therapeutic effectiveness and define end points for clinical trials. Surrogate markers for use in clinical trials are especially needed for diabetic neuropathy, as effective therapies for the prevention and treatment of diabetic neuropathy are not currently available. Diabetes is the most common cause of new cases of blindness among working age adults. As with other microvascular complications, risk is related to duration of diabetes and glycemic control. After 15 years of diabetes, almost all patients with type 1 diabetes and two thirds of patients with type 2 diabetes have background retinopathy. By the time visual acuity is affected, significant retinal damage has already occurred. Fluorescein angiography and fundus photography are effective methods for detecting retinopathy, however, these techniques can only be used to detect disease in its late stages, when some permanent visual loss has already occurred. Biomarkers are, therefore, needed to determine those at risk for developing retinopathy and for detecting disease at its earliest stages, so that more effective interventions can be used to prevent visual loss. In addition, because these techniques detect only late stages of retinopathy, trials of prevention or treatment regimens require long follow-up to detect clinically significant differences. Markers of early disease could potentially shorten the duration of clinical trials by allowing more sensitive detection of retinopathy progression. Objectives and Scope This RFA invites basic and clinical research applications to develop biochemical, cellular, physiologic or genetic surrogate endpoints that can be used to predict risk, aid in early diagnosis and assess progression of the microvascular complications of diabetes. The overall goal of this RFA is to develop biomarkers that could be used as diagnostic tools for the individual patient, or as outcome measures to be used in clinical trials testing new therapeutic agents. Ideally, such biomarkers will either predict susceptibility to retinopathy, nephropathy or neuropathy, detect early disease or correlate with pathological progression. Surrogate endpoints should be reliable, standardized and easy to use. Investigators responding to this RFA may wish to take advantage of existing epidemiological or long-term clinical studies that may have been established for investigation of diabetes or of other diseases. Studies in animal models will be considered responsive to this RFA if these applications have a clear-cut long-term goal of applicability to humans. Recent studies of the pathogenesis of diabetic microvascular complications may provide clues for potential surrogate markers of disease. For example, several growth factors have been implicated in the development of nephropathy, and some studies indicate that urinary excretion of TGF-beta may be an early marker of nephropathy. Other urinary or circulating biomarkers may predict risk for microvascular complications. In addition, recent advances in molecular biology may open up new avenues of exploration for the development of surrogate endpoints. Thus, the use of gene or protein microarrays could provide powerful tools to screen for novel biochemical, cellular or genetic markers associated with disease susceptibility or progression. New advances in imaging technologies also may provide opportunities to non- invasively detect microvascular abnormalities and develop physiologic markers that are associated with diabetic complications. A related RFA (DK 02-001) solicits applications to develop imaging techniques to measure perfusion, tissue oxygenation, angiogenesis or inflammation in the peripheral microvasculature of skeletal muscle beds in individuals with diabetes. Appropriate topics for investigation under this RFA would include but are not limited to: o Studies to identify and validate new biomarkers of early signs ( i.e., before the onset of symptoms) of retinopathy, nephropathy or neuropathy, o Studies to identify and validate new biomarkers that identify patients at risk for the development of retinopathy, nephropathy or neuropathy, o Studies to identify and validate new diagnostic tools that can be used to more sensitively monitor progression of retinopathy, nephropathy or neuropathy, including studies to assess the correlation between non-invasive markers of disease and pathological progression, o Studies to identify biomarkers that could be useful in predicting susceptibility to or development of multiple microvascular complications (e.g., retinopathy and nephropathy), o Studies to develop non-invasive measures of oxygenation or blood flow in relevant tissues (e.g., retina), o Studies, including ancillary studies to ongoing clinical trials, to clarify the predictive value of existing biomarkers or surrogate endpoints. 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. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA (PA) in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. LETTER OF INTENT Prospective applicants are asked to submit, by January 17, 2002, 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 NIDDK staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. All application instructions outlined in the PHS 398 application kit are to be followed, with the following modifications for R21 applications: The Research Plan for R21 applications cannot exceed 15 pages and appendix material will not be accepted. Further details regarding the purpose and format of R21 applications can be found by reading the NINDS guidelines describing the R21 program (http://www.ninds.nih.gov/funding/r21guidelines.htm). All R21 applications submitted in response to this Program Announcement should follow the NINDS guidelines, regardless of Institute assignment. Applicants may also contact one of the Program Officials listed under Inquiries for further information. If there is other important information it should be included in the PA. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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 NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. 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: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Applications must be received by the application receipt date listed in the heading of the RFA. If an application is received after that date, it will be returned to the applicant without review. Supplemental documents containing significant revision or additions will not be accepted, unless applicants are notified by the Scientific Review Administrator. 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 previously reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by program staff representing the participating NIH Institutes. 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 the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance 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. o 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? o 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? o 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? o 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)? o 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 Adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration to the proposed research. o The adequacy of the proposed protection of humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed in the application. o Availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources. Schedule Letter of Intent Receipt Date: January 17, 2002 Application Receipt Date: February 14, 2002 Peer Review Date: July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review, o Availability of funds, o Program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Barbara Linder, M.D, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 699 MSC 5460 Bethesda, MD 20892-5460 Telephone: (301) 594-0021 FAX: (301) 480-3503 E-mail: bl99n@mih.gov Paul Kimmel, M.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Rm. 639 Bethesda MD 20892-5458 Telephone: 301-594-7717 FAX: 301-480-3510 E-mail: pk77g@nih.gov Peter Dudley, Ph.D. Vision Research Program National Eye Institute Executive Plaza South, Rm. 350 Bethesda, MD 20892 Telephone: (301) 496-0484 FAX: (301) 402-0528 E-mail: pad@nei.nih.gov Paul Nichols, Ph.D. National Institute of Neurological Disorders and Stroke Neuroscience Center, Rm. 2118 6001 Executive Blvd. Bethesda, MD 20892 Telephone: (301) 496-9964 FAX: (301) 401-2060 E-mail: pn13w@nih.gov Direct inquiries regarding fiscal matters to: Charlette Kenley Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 640 MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8847 FAX: (301) 480-3504 E-mail: ck128k@nih.gov Margie Baritz Division of Extramural Activities National Eye Institute Executive Plaza South, Rm. 350 Bethesda, MD 20892-6600 Telephone: (301) 496-5884 FAX: (301) 496-9997 E-mail: mbaritz@nei.nih.gov Denise Chatman Grants Management Branch National Institute of Neurological Disorders and Stroke Neuroscience Center, Room 3290 6001 Executive Blvd. Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 E-mail: dc55g@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847, 93.849, 93.867, and 93.853. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 285) 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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