NONINVASIVE MEASUREMENT OF IRON BY MAGNETIC RESONANCE IMAGING (SBIR/STTR) RELEASE DATE: October 22, 2002 RFA: DK-03-009 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ( LETTER OF INTENT RECEIPT DATE: January 20, 2003 APPLICATION RECEIPT DATE: February 19, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) applications for support of projects that have the potential to improve the utility of magnetic resonance imaging as a method for quantitative determinations of tissue iron, especially in liver, heart and brain. A quantitative means of measuring body storage iron that would be non-invasive, safe, accurate and readily available would improve the diagnosis and management of patients with iron overload, including hereditary hemochromatosis, thalassemia major, sickle cell disease, aplastic anemia, myelodysplasia and other disorders. Magnetic resonance imaging potentially provides a useful and widely available technique for examining the three- dimensional distribution of excess iron in the body, but further research is needed to develop a way to make measurements quantitative. This Request for Application (RFA) must be read in conjunction with the OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION, AND FOOD AND DRUG ADMINISTRATION FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS (PHS 2002-2) (see See also NIDDK EXPANDED AWARDS FOR SBIR-AT-NIDDK ( All of the instructions within the Omnibus Solicitation apply with the following exceptions: o Special receipt dates o Initial review convened by the NIDDK Division of Extramural Activities o Additional review considerations This RFA will utilize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) mechanisms, but will be run in parallel with a Request for Grant Applications of identical scientific scope (RFA DK- 03-007) that will utilize the traditional research project grant (R01) or the exploratory/developmental (R21) grant mechanism. RFA DK-03-007 is available: (see RESEARCH OBJECTIVES Background The body iron burden is a principal determinant of clinical outcome in all forms of systemic iron overload, whether from transfusion (for thalassemia major, sickle cell disease, aplastic, myelodysplastic, or other refractory anemias), from increased dietary iron absorption (hereditary hemochromatosis and other forms of primary iron overload), or both (refractory anemia with increased ineffective erythropoiesis). Accurate assessment of the body iron is essential for managing iron-chelating therapy in transfused patients to prevent iron toxicity while avoiding the adverse effects of excess chelator administration. In hereditary hemochromatosis, determination of the magnitude of body iron stores permits identification of individuals who would benefit from phlebotomy therapy from among those at genetic risk for the disease. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored an international workshop on the non-invasive measurement of iron on April 17, 2001, to assess the current state of the science and to identify areas needing further investigation. The workshop participants concluded that additional work was needed to develop better quantitative means of measuring body storage iron that would be non-invasive, safe, accurate and readily available to improve the diagnosis and management of patients with iron overload. Currently, biomagnetic susceptometry (SQUID) provides the only non-invasive method for measurement of tissue iron stores that has been calibrated, validated and used in clinical studies. However, the complexity, cost and technical demands of the liquid-helium-cooled superconducting instruments required at present have restricted clinical access to the method. Magnetic resonance imaging was identified as an existing, widely available technology that, with further research, potentially could answer that need. Among conclusions reached, the workshop participants recommended further investigation of magnetic resonance imaging as a method for quantitative determinations of tissue iron, especially in liver, heart and brain. Detailed information on the workshop is available at the NIDDK website: Subsequently, an article summarizing the workshop and its recommendations has been published (Brittenham GM and Badman DG, Noninvasive Measurement of Iron: Report of an NIDDK Workshop, Blood First Edition Paper, prepublished online August 29, 2002; DOI 10.1182/blood-2002-06-1723; Under physiologic conditions, the concentration of iron in the human body is carefully regulated and normally maintained at about 40 mg Fe/kg body weight in women and about 50 mg Fe/kg in men, distributed between functional, transport and storage compartments. Iron overload arises from a sustained increase in iron supply over iron requirements and develops with conditions in which the regulation of intestinal iron absorption is altered (hereditary hemochromatosis, refractory anemia with ineffective erythropoiesis), bypassed (transfusional iron overload), or both. Regardless of the cause, progressive iron accumulation eventually overwhelms the body's capacity for safe sequestration of the excess, resulting in a variety of pathologies. The prognosis in patients with iron overload is influenced by many factors (Harmatz P, et. al. Severity of iron overload in patients with sickle cell disease receiving chronic red blood cell transfusion therapy. Blood. 2000; 96:76-79.) While ferritin and hemosiderin iron almost surely are not the species directly responsible for the adverse effects of iron, the overall magnitude of storage iron accumulation seems to be a principal determinant of clinical outcome in all forms of systemic iron overload. The reference method for evaluating the extent of body iron excess in systemic iron overload is measurement of the hepatic storage iron concentration (Brittenham GM, et. al., Noninvasive methods for quantitative assessment of transfusional iron overload in sickle cell disease. Semin Hematol. 2001;38:37-56). Total body iron stores can be measured by quantitative phlebotomy, but this approach cannot be used in transfusion- dependent patients with iron overload and is generally acceptable only if the procedure provides therapeutic benefit. The measurement of plasma ferritin provides an indirect estimate of body iron stores, but the usefulness of this measure is limited by the many common clinical conditions in which the plasma ferritin is not a reliable indicator of body iron. While liver biopsy with chemical analysis of tissue iron content provides the most quantitative direct measure of iron status generally available, the discomfort and risk of the procedure limits its acceptability to patients and precludes its frequent use in serial observations. Magnetic Resonance Imagining (MRI) uses the magnetic properties of the body to provide detailed three-dimensional images of any structure or tissue. With MRI, tissue iron is detected indirectly by the effects on relaxation times of ferritin and hemosiderin iron interacting with nearby hydrogen nuclei. The interactions are complex, involving factors such as tissue hydration, the water diffusion coefficient within the tissue, the distribution of iron and water within the tissue examined, the number of iron atoms per molecule of ferritin and hemosiderin (called the loading factor) and, because ferritin iron and hemosiderin iron have different effects on both T1 and T2 (Vymazal J, Urgosik D, Bulte JW. Differentiation between hemosiderin- and ferritin- bound brain iron using nuclear magnetic resonance and magnetic resonance imaging. Cell Mol Biol (Noisy-le-grand). 2000;46:835-842), the relative proportion of these two iron storage materials. Conventional MRI measurements are affected by the instrument used, the applied field strength, the repetition time used in the imaging sequence, the method used to analyze the relaxation curves, and other technical aspects of the measurement procedure. Comparison of absolute signal intensities from one MRI unit to another is unreliable because of substantial intermachine variation (Bonkovsky HL, et. al., Hepatic iron concentration: noninvasive estimation by means of MR imaging techniques. Radiology. 1999;212:227-234). In the absence of a theoretical understanding of the effects of iron on MRI, empirical efforts to estimate hepatic iron concentrations have used a variety of instruments, magnetic field strengths, imaging sequences (spin-echo, gradient recalled-echo), and parameters (T1 and T2 relaxation times, and signal intensity ratios as measured in proton, T1-, T2- or T2*-weighted images) but no standard or generally accepted method has been adopted for clinical application. To date, MRI has been more useful as a screening technique for the detection of marked iron overload than as a means for quantitative measurement. In particular, with increasing iron concentrations, the signal intensity of the liver is reduced to such an extent that discrimination between different concentrations becomes impossible (Angelucci E, et. al., Limitations of magnetic resonance imaging in measurement of hepatic iron. Blood. 1997;90:4736-4742), at least with current technology. Additional recent publications on both theoretical and practical efforts to develop non-invasive methods for measurement of tissue iron are presented in the article by Brittenham and Badman, referenced above. Research Goals and Topics At present, MRI provides a means of probing the three-dimensional distribution of excess iron in the body, but further efforts are needed to make measurements quantitative. The following are examples of basic and clinical research that could be addressed in the application of MRI to the measurement of tissue iron: o improve understanding of the contribution of ferritin and hemosiderin iron to magnetic resonance effects to guide development of optimal methods for measuring relaxation times and susceptibility, o improve techniques for data acquisition, choice of field strength, selection of timing parameters, reduction of noise, identification of region of interest and selection of analytic methods; o devise phantoms and/or other means for calibrating and validating iron concentration detected by magnetic resonance imaging that could enhance standardization between different laboratories; o develop new methods for non-invasive measurements of iron deposition in the heart, in endocrine tissue, and in specific areas of the brain to determine the role of abnormalities of brain iron in the pathogenesis of neurodegenerative disorders, including Alzheimer's disease, amyotrophic lateral sclerosis, prion diseases, mitochondrial disorders and Parkinson's disease. o determine whether a dual field approach, used by some for MRI measurement of brain iron with promise of greater accuracy than conventional single-field images, can be applied to assessment of liver iron. o investigate the most appropriate magnetic resonance method for determining relaxation times and susceptibility. o determine which data acquisition method is best with selected timing parameters. o develop improved methods of selecting a region-of-interest. o examine the mechanistic contribution of iron in iron-containing materials (e.g. ferritin and hemosiderin) to magnetic resonance relaxation, to be able to select the optimum measurement field strength and methods. These topics are suggestions for further research, only, and investigators are encouraged to develop and propose other lines of investigation relevant to the purposes of the RFA. MECHANISM OF SUPPORT This RFA uses the SBIR and STTR mechanisms, which are set-aside programs. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Future competing continuation applications based on this project will compete with all SBIR/STTR applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2003. Applications can be submitted for support as Phase I STTR (R41) or Phase I SBIR (R43) grants: Phase II STTR (R42) or Phase II SBIR (R44) grants; or under the SBIR/STTR FAST-TRACK option as described in the OMNIBUS SOLICITATION. Phase II applications in response to this RFA will only be accepted as competing continuations of previously funded NIH Phase I SBIR/STTR awards. The Phase II proposal must be a logical extension of the Phase I research. Information on the FAST-TRACK process and the OMNIBUS SOLICITATION are available at: FUNDS AVAILABLE The NIDDK intends to commit approximately $1,000,000 to fund five (5) Phase I and/or Phase II applications under the SBIR/STTR set-aside funding mechanism. Although the financial plans of the NIDDK provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. ELIGIBLE INSTITUTIONS Eligibility requirements are described in the OMNIBUS SOLICITATION. Any small business, independently owned and operated by United States citizens or permanent resident aliens, and located in the United States, may apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. On an SBIR project, the principal investigator must have his/her primary employment with the small business at the time of award and for the duration of the project. However under the STTR Program, primary employment is not stipulated. SPECIAL REQUIREMENTS In order to be responsive to this RFA, applications must focus on studies that could lead to improved quantitative MRI measurements of body iron in target organs (brain, heart, liver, endocrine organs) of iron overloaded individuals. Applications addressing alternative technologies will not be eligible for consideration and will be returned to the applicant. Upon initiation of the program, the NIDDK will sponsor annual meetings to encourage the exchange of information among investigators who participate in this program, perhaps in conjunction with other related Institute-sponsored programs. In the preparation of the budget for the grant application, applicants should include travel funds for the one meeting each year for the Principal Investigator and one additional senior investigator, to be held in Bethesda, Maryland. Applicants should also include a statement in the applications indicating their willingness to participate in such meetings. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: David G. Badman, Ph.D. Hematology Program Director National Institute of Diabetes and Digestive and Kidney Diseases 2 Democracy Plaza, Room 621 MSC 5458 6707 Democracy Blvd. Bethesda, MD 20892-5458 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: o Direct your questions about peer review issues to: Francisco O. Calvo, Ph.D. Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm.752, MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 Email: o Direct your questions about financial or grants management matters to: Ms. Aretina Perry-Jones Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 745 MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8862 FAX: (301) 480-3504 Email: LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Francisco O. Calvo, Ph.D. Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm.752, MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 Email: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at in an interactive format. Please refer to Chapter VI of the PHS 398 instructions prior to preparing a SBIR application. PHS 398 forms specific to SBIR applications are available: For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: The title and number of this RFA must be typed in Line 2 on the face page of the application. The OMNIBUS SOLICITATION gives the normal levels of support and period of time for SBIR and STTR Phase I and II awards. However, these award levels are guidelines and not ceilings. Therefore, larger budgets with longer periods of time may be requested if required to complete the proposed research. Projects requesting time or amounts greater than those published in the OMNIBUS SOLICITATION must be justified strongly. The second year of the Phase I budget should be included on the Budget Justification page, using categorical totals if costs deviate significantly from the first year of the budget, with narrative justifications for the increase(s). If the second year simply escalates due to cost of living factors, a statement to that effect with the escalation factor should be included rather than categorical totals. In order to apply for the FAST-TRACK option, applications for both Phase I and Phase II must be submitted together according to the instructions for FAST TRACK applications as described in the OMNIBUS SOLICITATION. The Phase I application must specify clear, well-defined quantifiable milestones that should be achieved prior to Phase II funding. Failure to provide measurable milestones and sufficient detail may be sufficient reason for the peer review committee to exclude the Phase II application from FAST-TRACK review. If so, at a later date, the applicant may apply for Phase II support through normal application procedures. Such applications will be reviewed by a standard Study Section of the Center for Scientific Review or by a special review group convened in response to a re-issuance of this RFA, if applicable. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: 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) At the time of submission, two additional copies of the application must be sent to: Francisco O. Calvo, Ph.D. Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm.752, MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 Email: APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. Incomplete applications will be returned to the applicant without further consideration. 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 to compete with other applications submitted in response to the next available receipt date of the OMNIBUS SOLICITATION. 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 NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. REVIEW CRITERIA The review criteria for SBIR and STTR applications are found at: _STTR_app.htm. ADDITIONAL CONSIDERATIONS: In addition to the above criteria, your application will also be reviewed with respect to the following considerations: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: January 20,2003 Application Receipt Date: February 19, 2003 Peer Review Date: June/July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA Criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. For FastTrack applications, the Phase II portion may not be funded until a Phase I final report and other documents necessary for continuation have been received and assessed by program staff that the Phase I milestones have been successfully achieved. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (; a complete copy of the updated Guidelines are available at The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at 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 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 Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.849 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)(or other authorizations) and administered under NIH grants policies described at (cite other relevant policies) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 (cite other relevant regulations). The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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