Full Text HD-95-007 COOPERATIVE MULTICENTER MATERNAL-FETAL MEDICINE UNITS NETWORK NIH GUIDE, Volume 24, Number 10, March 17, 1995 RFA: HD-95-007 P.T. 34 Keywords: Obstetrics - Gynecology Pregnancy Prenatal Factors National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 1, 1995 Application Receipt Date: June 16, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a Cooperative Agreement (U10) in an ongoing multicenter clinical program designed to investigate problems in clinical obstetrics, particularly those related to prevention of low birth weight. The objective of this program is to facilitate resolution of these problems by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and can provide answers more rapidly than individual centers acting alone. The NICHD program staff will assist the principal investigators of the MFMUs and the Advisory Board in identifying research topics of high priority, and in designing and implementing protocols appropriate to the evaluation of optimum management in these areas. It is anticipated that approximately 12 or 13 clinical centers will be involved in the program. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Cooperative Multicenter Maternal-Fetal Medicine Units Network, is related to the priority area of low birth weight. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit organizations, public and private. Organizations should have academically-oriented divisions of maternal-fetal medicine. The need for continuous and active communication among sites dictates that only institutions in the United States are eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U10), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activity by involvement in the activity and otherwise working jointly with the award recipients in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreements are discussed later in this document under the section "Terms of Agreement." The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is April 1, 1996. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will vary also. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. At this time, the NICHD has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE It is anticipated that 12 or 13 awards for Clinical Sites will be made, with an estimated total cost of $3,500,000 (including direct and indirect costs) for the entire program in the first year. Up to nine competing continuation awards and at least three new awards are expected. RESEARCH OBJECTIVES A. Background Modern obstetrical management, especially the management of high-risk pregnancies, has in some instances adopted principles of care, and at times employed pharmaceuticals and methodologies without rigorous use of the controlled observation necessary for their objective evaluation. Often the development of this medical specialty (and others as well) has been marked by the enthusiastic adoption of concepts and procedures followed by their modification or replacement, sometimes decades later, after extensive experience has failed to support their usefulness or shown unexpected consequences. Costs involved in instrument purchase and employment have often been large, and uncertainties embedded in such obstetrical practices have contributed at least partly to the rising incidence of cesarean delivery. Regional differences in practice have complicated the field. In an attempt to respond to the need for well-designed clinical trials in maternal-fetal medicine, NICHD established a Network of Maternal-Fetal Medicine Units in 1986. Seven university units were selected among respondents to an RFA. The Network Steering Committee, which consists of representatives from each clinical center, NICHD staff, and data coordinating center staff, evaluated several controversial issues for study. It then selected certain priority areas on which to develop protocols for randomized clinical trials. Trials were done on question of postterm pregnancy, management of preterm labor, and prevention of preeclampsia. A Data Monitoring and Safety Committee also advises NICHD on research design issues, data quality and analysis, and ethical and human subject protection aspects of protocols. During the second grant period of the MFMU Network (1991-1996), clinical trials were initiated on preterm premature rupture of membranes, prevention of preeclampsia in high-risk patients, predictors of preterm birth, obstetric predictors of neonatal survival, varicella in pregnancy, asthma in pregnancy, and bacterial vaginosis in pregnancy. The NICHD expects that ongoing clinical trials dealing with preterm labor, asthma and bacterial vaginosis will probably continue into the continuation grant period for existing centers. Centers that might join the Network in the next award period (beginning April 1, 1996) may participate in the protocols ongoing at that time. The NICHD intends to enable the Network to initiate new protocols within the first year of the next award period. The topics of these protocols will be decided cooperatively by the Steering Committee with advice from the Advisory Board. Areas of interest include: gestational diabetes mellitus, and techniques to reduce the risk of preterm labor and birth. B. Objectives and Scope There are a number of controversial issues in maternal-fetal medicine that might be clarified by multicenter collaborative research. Funded principal investigators will cooperate with the NICHD program officer in identifying research topics of high priority and in designing protocols appropriate to the evaluation of superior, or even optimal management in these areas. The participating maternal-fetal medicine units (MFMUs) will be designated as "clinical centers", and will recruit, assess and treat the subjects in the clinical research of the Network, with each MFMU being supervised by its respective principal investigator. The data center will have primary responsibility for data management and analysis for Network research in collaboration with the Steering Committee. C. Guidance and Management Structures The management of the MFMU Network includes three committees whose functions are as follows: 1. A Steering Committee will be responsible for protocol development, assisted by the Advisory Board and the Data Safety and Monitoring Committee. The Steering Committee will have primary responsibility for the conduct of protocols and the preparation of publications. The Steering Committee will be composed of all principal investigators, one representative from the data center, and three NICHD staff. NICHD staff will comprise the Director of the Center for Research for Mothers and Children (CRMC), an obstetrician from the Pregnancy and Perinatology Branch (MFMU program officer), and a representative from the Epidemiology and Biometry Research Program. The MFMU program officer will be the only voting NICHD staff member of the Steering Committee. An outside chairperson, who is not participating as a principal investigator, will be selected by the NICHD. 2. An Advisory Board will advise the Steering Committee in the identification and prioritization of topics for network research. The Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will be composed of individuals with expertise in clinical trials, biostatistics, epidemiology, perinatology, and neonatology; the Chairperson of the Steering Committee; the Director of the CRMC; and the MFMU program officer. Additional members will participate based on the need for specific expertise. 3. A Data Safety and Monitoring Committee will monitor the safety of ongoing clinical trials and advise on their conduct. It will be established by NICHD and will represent expertise in ethics, clinical trial design, perinatology, neonatology, and basic science. In addition, the Network has established Policies and Procedures that govern its operations, including publications. These documents are under periodic review, and may be amended and supplemented at the discretion of the Steering Committee. SPECIAL REQUIREMENTS The NICHD invites applications both from current members of the MFMU Network (competing renewal applications) and from prospective members (new applications). Minimum requirements for applicants are as follows (see also Review Criteria and Procedures, below): A. Requirements for Applicants 1. Academic Productivity Provide evidence of recent research productivity by the applicant Clinical Center in previous or present clinical trials, especially of a cooperative, multicenter nature. Specifically, contributions in key areas such as protocol design, patient recruitment, data analysis and interpretation, and publication are important. Applicants who are current MFMU Network members should describe their participation in Network research during the current competitive segment. New applicants should describe their recent participation in one randomized clinical trial, preferably of a multicenter nature. 2. Maternal-Fetal Staffing Physician staffing of the MFMU should include at least three maternal-fetal medicine subspecialists, each of whom would be available to take primary responsibility for one or more of the Network protocols at the unit. Provide complete descriptions of their training and qualifications in both clinical care and research, and their previous and current involvement in clinical research. Specifically, the academic status and academic career development pathways should be described. The approximate percentage time protected for research by the academic department should be specified. 3. Research Nurse Staffing A research nurse must be designated for the full-time nurse coordinator position. Also, additional research nursing staff should be available. Provide descriptions of these individuals' training, experience, and involvement in clinical research. 4. Available Population Applicant units must have at least 2,700 births per year currently in the unit, with a minimum of 30 percent documented to be high risk pregnancies. Applicants that have numbers of births near the minimum or which have experienced a decline in annual births in recent years, should document efforts to maintain access to an adequate number of obstetric patients for research purposes. A large majority of patients with obstetric complications who deliver in the MFMU must also receive prenatal care at the institution. The patient population served by the MFMU must be characterized by demographics, obstetric parameters, and payment status. Indications be given of the proportions of various subgroups, including minorities, that have been eligible, and have actually been randomized, in previous or current clinical trials (see also section on Inclusion of Women and Minorities). 5. Strengths of the MFMU A detailed description of the clinical attributes of the MFMU must be provided. This should include antenatal fetal testing, intrapartum diagnosis, laboratory testing, and perinatal pathology. Other institutional components related to the MFMU must also be described. In particular, the ambulatory facilities for prenatal and postpartum care must be presented, including the established policies and procedures for conducting clinical research in these facilities, in both low risk and complicated pregnancies. Also, the availability of an institutional pharmacy capable of supporting clinical research must be documented. Describe whether, and how, MFMU policies and procedures may have been modified, if necessary, to support clinical research in the past. 6. Perinatal Data System The MFMU unit must have an established perinatal data system, preferably computerized, to collect and tabulate perinatal statistics. Applicants must provide a detailed description of the variables collected, and the data quality and management activities. The applicant must also illustrate how the system has been used recently to plan and perform clinical research. 7. Neonatal Intensive Care Unit One or more neonatologists active in clinical research at the institution must be designated. Such individual(s) must commit to serve as a consultant and possible collaborator in Network research. The academic status and career development pathways of these individuals must be described. Describe the organization and service load of the NICU at the institution, including the existing newborn follow-up program and its research activities. 8. Proposed Protocol Concept (new applicants only) To provide peer reviewers and NICHD an idea of the capabilities of investigators, only new applicants must submit a "concept", briefly (2-3 pages) summarizing a protocol that the applicant might submit to the Network for possible implementation at all Network centers. The proposed "concept" will serve as an indicator of the applicant's ability to participate in the development and design of cooperative protocols in the Network. The "concept" or another design on the same topic, may or may not actually be performed by the Network. It is anticipated that funded MFMU centers will be invited to submit the "concepts" included in their applications to the Network Steering Committee. For purposes of this RFA only, the protocol "concept" must address ONE of the following topics: a. Tocolytics to prevent preterm birth after initial successful suppression of preterm labor. b. Morbidity associated with gestational diabetes mellitus. c. Antenatal steroids for preterm premature rupture of membranes (PROM). The "concept" should also demonstrate use of the applicant's perinatal data system to estimate numbers of available patients eligible for the protocol at the institution. The "concept" should also address relevant ethical issues and the appropriate inclusion of minorities as subjects. 9. Intent to Participate There must be a clearly expressed intent to participate in a cooperative manner with other MFMU units, the NICHD, and the data center, in all aspects of Network research, as outlined in this RFA. 10. Departmental and Institutional Commitments The departmental and institutional commitments to collaborative maternal-fetal research should be clearly documented by letters to the Principal Investigator, and by citing evidence of past support. 11. Acceptance of Budgetary Mechanism Assurance of cooperation with the policy of capitation of research costs for each individual protocol, in addition to a base budget, should be provided from the department and from the institutional office of sponsored research programs. B. Optional: Special Strengths Available to The MFMU Unit All applicants, both competing renewals and new, are also invited to describe briefly any special research strengths of the MFMU that may be relevant to Network research. Such strengths would represent state-of-the-art scientific capabilities that might be shared or made available to the Network, to expand the scientific productivity of the research, over what it might be otherwise. For example, capabilities in areas such as genetics, placental function, or clinical pharmacology, are examples of relevant strengths that could be included. Special administrative strengths may also be described. For example, both competing and new applications may also present the availability of potentially collaborating maternal-fetal medicine units in medical centers with which affiliations have been developed by the applicant institution for the purpose of clinical research. The same requirements (above) must be met by such affiliated institutions. Another example of an administrative strength would be linkage with ongoing, specialized registries. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. C. Budget Preparation The instructions for budget requests provided with the research grant application form (PHS 398) should be followed. Indirect costs will be awarded in the same manner as for research project grants (RO1). Budgets will be reviewed on the basis of appropriateness for the work proposed. Allowable costs and policies governing the research grants programs of the NIH will prevail. In planning the budget section of the application each applicant should submit budget estimates for all years. The first-year budget at the time of application will be limited to a BASE BUDGET with maximum allowances as follows: Principal Investigator 10% effort Research Nurse Coordinator 100% effort Data Entry Clerk 50% effort Supplies and Small Equipment (itemized and justified) NTE $4,500 Travel (a total of 10 trips to Bethesda per Network team) as appropriate Other costs (itemized and individually justified) NTE $2,500 When an application has been favorably recommended and is being considered for funding, the applicant will be required to complete protocol budgets for those studies underway within the network. These budgets will consist of specific protocol-related allowances and will be capitated on the anticipated number of subjects to be enrolled in the study at the applicant MFMU. Ongoing annual budgets of MFMU Network members will be based on individual protocols that will be funded through a capitation system. Each MFMU Network member will be given base costs (listed above), in addition to a flat fee per patient successfully enrolled and completed. The individual members will be required to project patient enrollment for a specific protocol during a specified time frame; continuation and level of funding will be based on actual recruitment. Future years' budgets should be limited to base budget costs, with an annual increment not to exceed four percent. Terms of Agreement The funding mechanism to be used to assist the scientific community in undertaking this system of clinical investigation will be a Cooperative Agreement between the participating units and NICHD. The major difference between a Cooperative Agreement and a research grant is that there will be substantial programmatic involvement of NICHD staff above and beyond the levels required for traditional program management of grants. Specifically, the role of the NICHD Maternal-Fetal Research network program officer will be to aid the awardees and the Steering Committee in the following ways: o Assistance in the identification of important areas of study. o Assistance in the development of study protocols. o Assistance in the development and review of capitation-based budgets, including the identification of study costs and special institutional needs. o Assistance in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee, and the Advisory Board. o Assistance in reporting results in the community of investigators and health care recipients. Programmatic responsibility for scientific review and oversight of these Cooperative Agreements will reside with the MFMU Network program official. This role will include the following: o Assurance of the scientific merit of the trials. The NICHD reserves the right to terminate support of a participating center if technical performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met; if a study reaches a major endpoint substantially before schedule; or, if an ethical issue dictates premature termination. o Assistance in the efficient conduct of the trials, including ongoing review of progress; possible redirection of activities to improve performance and cooperation; and frequent communication with other members of the Steering Committee. o Initiation of a decision to modify or terminate a study based on the advice of the data center, Data Safety and Monitoring Committee, and Advisory Committee with the mutual consent of the Steering Committee. The responsibilities and authorities of the awardees will be as follows: o Identification of priority issues for research. o Development and implementation of protocols. o Collection and transmission of accurate data in a timely manner. o Analysis of data and publication of results of the MFMU trials. All parties will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process. The specific terms, conditions, and details of arbitration procedures pertaining to the scope and nature of the interaction between NICHD and the participating MFMUs will be incorporated into the Notice of Grant Award. These procedures will be in addition to the customary programmatic and financial negotiations that occur in the administration of grants; they will be invoked only when agreement cannot be reached between the awardee and the MFMU program officer on issues that may arise after the award. In that event, an arbitration panel will be formed consisting of one person selected by the principal investigators, one person selected by the Chief of the Pregnancy and Perinatology Branch, and a third person selected by these two members. The decision of the arbitration panel will be binding. Terms of Award of Cooperative Agreement are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS grant administration regulations at 45 CFR Part 74 and other DHHS, PHS, and NIH grant administration policies. The NICHD review procedure in no way affects the right of a recipient of a cooperative agreement to appeal an adverse determination under the terms of PHS regulations at 42 CFR Part 50, Subpart D, and DHHS regulations at 45 CFR Part 16. Business management aspects of these awards will be administered by the NICHD Office of Grants and Contracts in accordance with DHHS, PHS, and NIH grant administration requirements. 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 subpopulations 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 that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59-14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1995, 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 informtation that it contains allows the NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Donald McNellis at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-710-0267. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. 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, COOPERATIVE MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS (MFMUs) HD- 95-007, must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Division of Research Grants National Institute of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20893-7710 Bethesda, MD 20817 (for express mail) At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Executive Building, Room 5E03F 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Applications must be received by June 16, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) 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 DRG 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. Schedule Letter of Intent Receipt Date: April 1, 1995 Application Receipt Date: June 15, 1995 NICHD Council Review: January 1996 Earliest Award Date: April 1, 1996 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NICHD. 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 Division of Scientific Review, NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria a. Qualifications, Experience, and Commitment of Key Personnel. o Scientific, clinical, and administrative abilities and academic productivity of the principal investigator and other team members; o Knowledge and experience in areas relevant to the conduct of collaborative clinical research, especially randomized clinical trials, in maternal-fetal medicine. This should include specific experience in research design; o Commitment of staff time for the satisfactory conduct of the study; o Experience and qualifications of team members who would be responsible for data quality and management activities. b. Protocols and Procedures o Quality of the unit's participation in either (1) (new applicants) a randomized, clinical trial in the recent past, or (2) (current Network members) Network protocols during the current grant period; o Willingness to work and cooperate with other MFMUs and the NICHD in the manner summarized in this RFA; o Quality of the proposed "concept" protocol designed to be undertaken by the Network (new applicants only); o Optional research strengths, as presented. c. Facilities and Management o Adequacy of administrative, clinical, and data organizational management facilities as described in the minimum requirements; o Institutional assurance to provide support to the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning and budgeting; o optional administrative strengths, such as affiliations with other research units. d. Budget - Appropriateness of the Proposed Budget o Adequacy of plans to include both genders and 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. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications recommended by the NACHHD Council will be considered for award based primarily on scientific and technical merit. Program balance, that is, the scope and variety of research strengths to enable a successful collaborative program, will be considered. Final selection of Clinical Centers for funding may be partly based on the need for diversity in the study population. Availability of funds may also determine the awards made. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Donald McNellis, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Building, Room 4B03 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5575 FAX: (301) 496-3790 Email: mcnellid@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Ms. Mary Ellen Colvin Office of Grants and Contracts National Institute of Child Health and Human Development Executive Building, Room 8A17G 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (3010 402-0915 Email: colvinm@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.3, 93.865. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 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 routing 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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