MOLECULAR THERAPY CORE CENTERS RELEASE DATE: September 13, 2002 RFA NUMBER: DK-02-034 (Reissued as RFA-DK-07-010) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ( LETTER OF INTENT RECEIPT DATE: January 13, 2003 APPLICATION RECEIPT DATE: February 13, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism 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 applications for Core Center Grants to support molecular therapy research to develop treatments for cystic fibrosis and other genetic diseases of interest to NIDDK. Core Centers will provide shared resources to enhance the efficiency of research and foster collaborations within and among institutions with strong existing base of research relevant to gene transfer and gene correction technologies. Centers will also support a Pilot and Feasibility Program and an Educational Enrichment Program. This program is intended to foster research toward the goal of developing molecular therapies for the treatment of cystic fibrosis. Therefore, applicants should propose a central focus on molecular therapy for cystic fibrosis. Centers should also have a focus on development of new approaches for gene transfer and achieving gene correction. Many common principles are involved in the development of safe methods for targeting and achieving long- term expression of therapeutic genes for most genetic disease. Therefore, Core Center resources may also be made available to scientists developing gene therapy and gene correction approaches for genetic endocrine, metabolic, digestive, liver, kidney, urologic, and hematologic diseases. RESEARCH OBJECTIVES Background Cystic Fibrosis is one of the most common, life-limiting, genetic diseases, affecting 30,000 Americans. Treatment has extended the mean life expectancy of patients with CF to 30 years but clearly additional improvements in care are needed. Although the lung disease is the primary cause of death in CF, multiple organs systems have altered function in CF including the lung, liver, pancreas, sweat glands, GI and reproductive systems. Treatment for CF will ultimately need to address many of its diverse problems. The development of gene transfer or gene correction approaches to treating CF will also require a variety of techniques to target affected organs and cell types. Although the gene causing CF, the cystic fibrosis transmembrane conductance regulator (CFTR), has been known for many years, the function of the gene and its relationship to the pathophysiology of the disease is not completely understood. New functions for CFTR throughout development are being uncovered and new interactions with other cellular proteins are being discovered. Until the mechanism for the pathogenesis is understood, replacing or correcting the defective gene may be the most straightforward approach to therapy. Several gene transfer strategies have been applied to CF. Clinical trials have been conducted with viral vectors including adenovirus and AAV2 as well as DNA/cationic lipid formulations. None of these methods corrected a large enough population of cells to show clinical improvement. Preclinical studies are underway with new vectors such as lentivirus and new AAV serotypes with promising results. New molecular technologies are being investigated to correct the genetic defect by homologous recombination, to correct CFTR RNA by trans-splicing, and to correct the CFTR protein by suppressing stop codons. These are attractive choices since they would provide a means to correct the genetic defect while maintain normal gene regulation. In addition to testing the efficacy of gene delivery methods, it is crucial to assess toxicity. Toxicity can result from many different causes including the presence of viral protein, the vehicle used to administer the DNA or the expression of the therapeutic gene product. By identifying the cause and the mechanism of the toxicity, the elements that create problems can be altered to design more effective vectors. Another important problem that has been identified is the lack of viral receptors on the cell types being targeted. For example, the adenoviral receptor CAR is not found on the lung epithelial surface. An understanding of the biology of the target cell, especially the polarized cell, is needed in order to design a compatible method for gene delivery. In addition, by altering the viral envelope proteins different receptors on cells or different cell types can be targeted to direct gene delivery. The NIDDK-supported Molecular Therapy Core Centers (formerly called Gene Therapy Core Center) are part of an integrated program of cystic fibrosis and metabolic disease research. These Core Centers provide increased, cost- effective collaboration among multidisciplinary groups of investigators at institutions with an established, comprehensive research base in cystic fibrosis and other genetic diseases. Additionally, NIDDK supports three Specialized Centers of Research (P50) and one Core Center Grant on cystic fibrosis. NIDDK supports a large body of research on cystic fibrosis and genetic metabolic diseases and molecular therapies for these disorders through regular research and program project grants. Molecular Therapy Core Center grants for cystic fibrosis and other genetic diseases are intended to improve the quality and multidisciplinary nature of research on molecular therapy of these disorders by providing shared access to specialized technical resources and expertise. Objectives and Scope The objective of the Molecular Therapy Core Centers is to provide shared resources to investigators with a wide variety of relevant expertise to promote a multifaceted approach to gene transfer and gene correction research. Gene therapy research involves many specialized technologies that need to be integrated into a cohesive research program. A Molecular Therapy Core Center would make these technologies available to many investigators to apply to their research. In order to be competitive for a Molecular Therapy Core Center, the applicant institution must have a substantial research base in gene transfer and gene correction approaches for the treatment of cystic fibrosis and other genetic metabolic diseases. Because current methods for gene transfer appear to be inadequate, a research base that is developing, testing, and improving methods for gene transfer and gene correction is important. A biomedical research core is defined as a shared resource that provides essential services, techniques, or instrumentation to Center participants enabling them to conduct their funded individual research projects more efficiently and/or more effectively. Cores provide specialized technologies and expertise needed to accomplish the stated goals of the Center toward molecular therapy for cystic fibrosis and other genetic diseases of interest to NIDDK. Each core should provide services to multiple funded research projects. Examples of possible biomedical core resources that would be considered responsive to this Request for Applications include: o Vector core to develop and design new vectors, assist investigators with the construction of vectors, provide vectors for experimentation, and monitor vector preparations and patient samples for adventitious agents and replication competent viruses. o DNA Delivery core to develop, distribute and test new formulations for liposome or other DNA compacting and targeting reagents for delivery of DNA. o Animal Models core to develop, breed and maintain models for cystic fibrosis, to develop new models using knockout technology for other genetic metabolic diseases, and crossbreed mice on to new background strains to attain appropriate models for in vivo assessment of molecular therapies. o Histology core to assess the efficiency of gene transfer or gene correction to particular cell types by using enzymatic histochemistry, immunohistochemistry, in situ hybridization or in situ polymerase chain reaction (PCR). o Cell Transduction core to develop techniques for transduction or correction of cells ex vivo and techniques for re-implantation of modified cells. This core may also support the development of techniques for ex vivo selection of transduced or corrected cells. o Electrophysiology core to measure the functional correction of CFTR in cystic fibrosis cell lines and patient samples. o Immunology core to analyze in vivo immunological responses to therapeutic genes, viral proteins, and DNA delivery agents and to study methods to suppress these reactions. o Clinical core to design, conduct, monitor and provide statistical support for molecular therapy clinical trials for cystic fibrosis and other genetic diseases. These possible cores are not listed in any particular order nor do they represent a comprehensive list of cores that could be supported under this Request for Applications. Applicants are encouraged to propose other cores that address the program objectives as stated above. In addition to biomedical cores, an administrative core must be described which will be responsible for allocation of resources within the Center and distribution of resources to Center participants. The Administrative core will also be responsible for planning the Educational Enrichment Program consisting of a seminar series, guest lectures, and workshops, and convening a Committee to oversee the solicitation, review and selection of the pilot projects. Although funds are not provided directly for training purposes, the core laboratories and program enrichment activities should provide training opportunities for Center members. Each Core Center must develop a cohesive Pilot and Feasibility Program to develop new research directions or provide an opportunity for new investigators or established investigators to enter the field of gene therapy. A pilot and feasibility project is intended to provide modest support that will allow an investigator the opportunity to develop sufficient preliminary data as a basis for an application for independent research support. Pilot and feasibility projects are not intended to support or supplement ongoing research of an established investigator. This Program should be integrated into the overall research goals of the Center and make use of the resources provided by the cores. Each Core Center application must include a minimum of two up to a maximum of five pilot projects. Each pilot project may request a maximum of $50,000 direct costs per year for up to two years. A comprehensive description of the Pilot and Feasibility Program can be found in the Administrative Guidelines. MECHANISM OF SUPPORT This RFA will use NIH core center research grant (P30) award mechanism. Applicants will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award dates are September 30, 2003 and/or January 1, 2004. FUNDS AVAILABLE The NIDDK intends to commit approximately $2,150,000 in FY 2003 and $1,700,000 in FY 2004 to fund up to 2 new and/or competing continuation grants in each year in response to this RFA. The receipt of four competing continuation applications is anticipated. An applicant must request a project period of up to 5 years and a budget for direct costs of up to $750,000 per year. Any indirect costs related to subcontracts are not included in the $750,000 direct cost limit. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. 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 this RFA will be reissued. ELIGIBLE INSTITUTIONS An outstanding existing program of biomedical research in the area of molecular therapy for cystic fibrosis and other genetic diseases is required. The research base for the Center must consist of at least $1,000,000 total annual costs of peer reviewed research projects employing gene transfer or gene correction approaches to treating CF. You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic 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. SPECIAL REQUIREMENTS An existing program of excellence in biomedical research in the area of gene transfer and gene correction for cystic fibrosis and related genetic metabolic diseases is required. This research base must consist of the NIH and other peer-reviewed funded research projects and be substantial to justify the requested Core support. Suggestions for describing and presenting this research base in the application are included in the Administrative Guidelines. 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: Catherine McKeon, Ph.D. Senior Advisor for Genetic Research Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 9707 Democracy Boulevard, Room 6103 Bethesda, MD 20892-5460 Telephone: (301) 594-8810 FAX: (301) 480-3503 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: Kieran Kelley Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 721 Bethesda, MD 20892-5456 Telephone: (301) 594-0417 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: 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 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. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: SUPPLEMENTAL INSTRUCTIONS: Applicants should consult the "Administrative Guidelines for Molecular Therapy Core Centers" located at These guidelines contain important additional information on the format, content, and review of the applications and review criteria. 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 three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: 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) 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 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: 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 goals of the MTCC are to facilitate development of gene transfer and gene correction approaches to treat CF and other genetic metabolic diseases. 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, weighing them as appropriate for each application. The most important component of MTCCs is the quality (strengths, breadth and depth) of its established, independently supported, ongoing base of research to develop molecular therapies for CF at the institution(s) to be served by the center. Specific review criteria are: o Scientific excellence of the Center"s research base that must have a broad and central focus in molecular therapy for CF and may extend to related research in other genetic metabolic disease. The relevance of the separately funded research to the Center objectives (see above) and the likelihood for meaningful collaboration among Center investigators must be demonstrated. o Potential of the cores for contribution to ongoing research, including their appropriateness, impact, relevance, uniqueness, modes of operation, and suitability of facilities. Renewal applications must document the use, impact, quality control, and cost effectiveness of each core, and demonstrate progress of any developmental research in the cores. Progress will be judged in part by the publications supported by the cores. While a minimum of two users (exclusive of Pilot and Feasibility projects) are required to establish a core, a greater number of users will be considered to be more cost effective. o Scientific and administrative abilities of the Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the Molecular Therapy Core Center. o The qualifications, experience, accomplishments, and commitment of the Center investigators and their inter-relatedness and collaborations. o The Administrative organization proposed, including: coordination of ongoing research, establishment and maintenance of internal communication and cooperation among MTCC investigators, mechanisms for prioritizing usage of shares resources, mechanisms of selecting and replacing essential personnel within the Center, mechanisms for reviewing the use of and administering funds for the pilot and feasibility program, and management capabilities. o The appropriateness of the MTCC budgets for the proposed and approved work to be done in core facilities, for pilot and feasibility studies, and for enrichment in relation to the total Center program. o Institutional commitment to the program, including lines of accountability regarding management of the MTCC grant and a commitment to establish new positions as necessary. o For new applications, the pilot and feasibility program is judged on the basis of: (1) scientific merit of the studies as submitted and (2) the merit of the administrative process for selecting subsequent studies. The scientific merit of the submitted pilot and feasibility studies will be evaluated for: (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Does the PI meet one of the eligibility criteria set out in the Administrative Guidelines for pilot and feasibility studies? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In competing renewal applications, emphasis is placed on the pilot and feasibility program as a whole, including past track record and management of the program. o Although the MTCCs do not specifically support research training, demonstration of accomplishments and future plans related to the training of investigators necessary to conduct research in cystic fibrosis and related metabolic diseases will be considered in assessing the potential to meet Center objectives. The integration of these efforts into the overall Center, including core facilities is of particular importance. Efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities in enhancing the objectives of the Center will also be considered. 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: January 13, 2003 Application Receipt Date: February 13, 2003 Peer Review Date: June or July, 2003 Council Review: September 24 and 25, 2003 Earliest Anticipated Start Date: September 30, 2003 and/or January 1, 2004 AWARD CRITERIA Award 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. 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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. 93.847, 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) and administered under NIH grants policies described at and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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