INFECTIOUS ETIOLOGY OF CHRONIC DISEASES: NOVEL APPROACHES TO PATHOGEN DETECTION Release Date: February 14, 2001 RFA: RFA-AI-01-004 National Institute of Allergy and Infectious Diseases National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases Office of Research on Women’s Health Letter of Intent Receipt Date: April 16, 2001 Application Receipt Date: May 15, 2001 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The purpose of this Request for Applications (RFA) is to solicit applications for research projects that propose developing novel technologies or improving established technologies to enhance the ability to identify and validate the role of microbial pathogens in chronic diseases and cancer for which an infectious etiology is suspected. Areas of particular interest are studies using recent technological approaches in genomics, molecular biology, proteomics and computational biology. The creation of interdisciplinary collaborative research teams is encouraged. It is anticipated that the availability of innovative methods for detecting and identifying the infectious agent will stimulate avenues of research for studying the pathogenesis and etiology of chronic diseases and cancer. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This Request for Applications (RFA), “Infectious Etiology of Chronic Diseases: Novel Approaches to Pathogen Detection” is related to one or more of the focus areas. Potential applicants may obtain a copy of "Healthy People 2010" at ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for R21 grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support will be the NIH individual research project grant (R01) and Exploratory/Developmental Research Project Grant (R21). The total requested project period for an application submitted in response to this RFA may not exceed four years for an R01 and two years for an R21. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The R21 mechanism is particularly appropriate and encouraged for research technology development. R21 grants will be used to provide short-duration support for preliminary studies of a highly speculative nature, which are expected to yield, within this time frame, sufficient information upon which to base a well-planned and rigorous series of further investigations. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at A notice of modification and update (OD-00-046) regarding modular grants was released on 7/24/00 and can be found at This RFA is a one-time solicitation. Future competing renewal applications will compete with all investigator-initiated applications and will be reviewed according to customary referral and review procedures. For administrative reasons all applications received in response to this RFA will be assigned initially to NIAID. After discussions among the participating Institutes, applications will be reassigned to the Institute(s) that is programmatically most appropriate. Because the scope of some of the research projects proposed in response to this RFA encompasses the interests of several NIH institutes, applications may receive dual assignments based on established PHS guidelines. Awards will be made and managed by NIAID and/or the other participating institutes. FUNDS AVAILABLE The estimated total funds, (direct and Facility & Administrative (F&A) costs), available for the first year of support for all awards made under this RFA will be $3,000,000. In fiscal year 2002, the NIH plans to fund approximately 5-10 awards. Although this program is provided for in the financial plans of the sponsoring institutes, awards pursuant to this RFA are contingent upon the availability of funds for this purpose and the receipt of a sufficient number of applications of high scientific merit. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background Chronic diseases contribute significantly to worldwide morbidity and mortality. In the United States chronic diseases account for 70% of all deaths and 61% of all health care costs. Recent evidence indicates that microbial organisms play a role in the pathogenesis of a number of chronic diseases, including some cancers and a variety of cardiovascular, respiratory, gastrointestinal, and neurological diseases. Examples include peptic ulcers and gastric cancer(Helicobacter pylori), as well as Lyme arthritis and neuroborreliosis (Borrelia burgdorferi). In addition, there are a number of chronic diseases in which an infectious etiology is likely, but not proven. Recently, an association between Chlamydia pneumonia infection and the development of atherosclerosis in human and animal models has been noted. In a number of chronic diseases an infectious etiology has been suggested. Crohn’s Disease and Mycobacterium paratuberculosis or adherent E. coli have been suggested as potential etiologic agents. In colon rectal cancer Streptococcus bovis and schistosomes have been implicated as possible etiologic agents. Infectious agents may be involved in the pathogenesis of urologic and renal diseases such as nephrolithiasis, chronic prostatitis, and interstitial cystitis, and interstitial nephritis and immune complex renal diseases, such as various forms of glomerulonephritis. Infectious organisms have been implicated in the pathogenesis of a number of gastrointestinal and hepatic chronic diseases including ulcerative colitis, tropical sprue, necrotizing enterocolitis, celiac diseases, sclerosing cholangitis, biliary atresia, achalasia, autoimmune and cryptogenic hepatitis, acute liver failure and possibly obesity. In addition, viral agents have been suggested as possible triggers for an autoimmune process, which culminates in development of Type 1 Diabetes or immune complex renal disease in genetically susceptible individuals. The detection of the pathogen and validation of its role in chronic diseases is critical to establishing an infectious etiology and development of effective treatment and prevention strategies. Research Objectives and Scope The purpose of this initiative is to stimulate research on the infectious etiology of chronic diseases and cancer and in particular, to focus on developing novel or improved technologies for the detection and identification of microbial pathogens in tissue samples from patients with chronic diseases and cancer. This research is critical for establishing an infectious etiology for chronic diseases and cancer, especially for those diseases for which an association with a specific pathogen is minimal, weak, or absent. This RFA encourages the use of recent technological advances in genomics, molecular biology, proteomics and computational biology to develop innovative approaches for pathogen detection and identification. Collaborative arrangements are also encouraged, in which scientists with expertise in epidemiology, pathology, clinical aspects of chronic diseases, molecular biology, and computational biology, and genomic technology work together to apply innovative approaches for identifying the infectious agents in chronic diseases. The search for an infectious cause of chronic diseases is particularly difficult when the organisms replicate slowly or not at all in culture, are present in low numbers or are present early or transiently in the disease process. Advances in DNA sequencing technology have allowed scientists to rapidly and efficiently sequence DNA of microbial genomes. Having access to the DNA sequence of entire microbial genomes has, and will continue to, provide an enormous amount of information about the microbe and facilitate the development of more sensitive and specific methods for universal analysis of microorganisms in biological samples. It is anticipated that genomic targets of microbial nucleic acid sequences or gene families can be used for pathogen detection in biological tissues. Host global gene or protein expression profiles, reflecting responses in the host to a particular infectious agent, also have the potential to provide novel approaches to microbial pathogen identification. The identification of a particular microbial pathogen as the etiologic agent responsible for a chronic disease will allow research to progress on studying the mechanism of microbial pathogenesis, as well as design of new treatment and prevention strategies for that disease. This RFA is intended to support research that will develop novel technologies or improved ones for the detection and identification of microbial pathogens in tissue samples. The sharing of biomaterials, data, software and research technologies in a timely manner has been an essential element in the rapid process that has been made in the genetic analysis of mammalian and microbial genomes. NIH policy requires that investigators make unique research resources readily available for research purposes to qualified individuals within the scientific community when they have been published [NIH Grants Policy Statement (, Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999]. NIH is interested in ensuring that research resources developed through this RFA become readily available to the research community for further research, development and application. Research technologies and resources produced in projects funded by this RFA are expected to be made available and disseminated to the scientific community. Applicants are therefore expected to address in the application the timely and broad dissemination of these research resources to scientific community, essential in studying the infectious etiology of chronic diseases and cancer. Research topics of interest include, but are not limited to, the following: o Development of novel or established approaches for wide screening methods for universal pathogen detection in biological specimens using, for example, sequence-based methods such as PCR technology and DNA microarrays, or emerging technologies that are designed for identification, quantitation and analysis of gene products and their interactions including mass spectrophotometry, protein arrays and biosensors. o Validation of new and novel technologies for the identification and investigation of pathogens involved in chronic diseases and cancer. Representative studies for technology validation should include initial infection, and/or determination of etiologic role for new agents, and/or progression to chronic diseases and cancer. o Development of innovative approaches to identify infectious agents in chronic diseases and cancer for which there may be a long interval between initial exposure to a pathogen and the subsequent development of clinically manifest disease. o Development of improved techniques for subtractive hybridization methods such as representational difference analysis for identifying unique nucleic acids of microbial origin, including oncogenic viruses in biological specimens. o Development of methods for studying the host response to infection from the microbial pathogen using state-of-the-art technologies for examining global gene or protein expression in the host cell, identifying possible diagnostic signatures that may distinguish infection by a particular pathogen and may include using genetically manipulated animals such as transgenic or gene knockout animals. o Development of methods to isolate and express microbial and viral sequences that encode clinically relevant antigens leading to serological test for microbial detection, as well as tissue immunochemical staining procedures. o Development of bioinformatics tools to assist in facilitating pathogen identification in chronic diseases such as development of databases and software algorithms for processing and analyzing microarray data, genomic comparisons and DNA sequence or protein analysis for identifying gene families and protein structures such as antigenic sites and membrane proteins. TERMS AND CONDITIONS OF AWARD When clinical studies or trials are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. Terms and Conditions of Award will be included with awards. NIAID policy was announced in the NIH Guide on February 24, 2000 and is available at: The full policy including terms and conditions of award is available at: STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear, 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (, a complete copy of the updated Guidelines are available at: The revisions relate to NIH-defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and which is available at the following URL address: Investigators may obtain copies from these sources or from Maria Y. Giovanni, Ph.D. (listed in INQUIRIES below) who may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit, by April 16, 2001, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. Although the 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 NIAID staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent to Dr. Eleazar Cohen at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are strongly encouraged to call program staff of the sponsoring ICs with any questions regarding the responsiveness of their proposed project to the goals of this RFA. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: In addition, the application kits can be found on the following URL: SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET NARRATIVE JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. Under Personnel, provide budget narrative for ALL personnel by position, role and level of effort. This includes consultants and any “to be appointed” positions. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include a Letter of Commitment or Intent if there is or is to be a subcontract/consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all KEY personnel, including consultants, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. Applicant institutions should calculate the Facilities and Administration (F&A) costs using the current negotiated F&A rate, less exclusions, for the initial budget period and all future budget periods. It is not necessary to list the exclusions on the Checklist nor anywhere in the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number "AI-01-004" and the words "Infectious Etiology of Chronic Diseases: Novel Approaches to Pathogen Detection" must be entered on the face page. Applications must be received by May 15, 2001. Applications not received as a single package on the receipt date or not conforming to the instructions, including page limitations and font size, contained in PHS 398 Application Kit (rev. 4/98) (as modified in, and superseded by, the special instructions below, for the purposes of this RFA), will be judged non-responsive and will be returned to the applicant. The RFA label and line 2 of the application should both indicate the RFA number. The RFA label must be affixed to the bottom of the face page. 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. The sample RFA label available at: has been modified to allow for this change. Please note this is in pdf format. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but that has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application that is essentially identical to one that has already been reviewed cannot be submitted in response to this RFA. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided 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 mail or courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to: Dr. Eleazar Cohen Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3239, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 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. 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 should be included with the application. REVIEW CONSIDERATIONS Review Considerations Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review and for responsiveness by NIAID staff, those judged to be incomplete will be returned to the applicant without review. Those considered to be non-responsive will be returned without review. 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 Extramural Activities, NIAID in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level of review provided by the appropriate NIH National Advisory Council. Review Criteria The criteria to be used in the evaluation of grant applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques 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 by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The Scientific Review Group will also comment in an administrative note on the sharing and dissemination of research resources including, but not limited to, methods, protocols, and software to the scientific research community that may be developed in the research supported through this RFA. The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include children and both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. Schedule Letter of Intent Receipt Date: April 16, 2001 Application Receipt Date: May 15, 2001 Scientific Peer Review Date: September/October 2001 Advisory Council Date: January 2002 Earliest Anticipated Award Date: April 2002 AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, programmatic priorities, and the availability of funds. The earliest anticipated date of award is April 1, 2002. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic (research scope and eligibility) issues to: Dr. Maria Y. Giovanni Division of Microbiology and Infectious Disease National Institute of Allergy and Infectious Diseases Room 3146, MSC-7630 6700-B Rockledge Drive Bethesda, MD 20892-7630 Telephone: (301) 496-1884 FAX: (301) 480-4528 E-Mail: Dr. Jack Gruber Division of Cancer Biology National Cancer Institute Room 5012, MSC-7398 Executive Plaza North Bethesda, MD 20892-7398 Telephone: (301) 496-9740 Fax: (301) 496-2025 E-mail: Dr. Jose Serrano Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Room 671, MSC 5450 2 Democracy Plaza Bethesda, MD 20892-5450 Telephone: (301) 594-8871 FAX (301) 480-8300 Email: Dr. Lisa Beggs Research Programs Office of Research on Woman’s Health Room 201 MSC 0161 Building 1 9600 Rockville Pike Bethesda, MD 20892-0161 Telephone: (301) 402-1770 FAX: (301) 402-1798 Email: Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Dr. Eleazar Cohen Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3239, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) 496-2550 FAX: (301) 402-2638 E-Mail: Direct inquiries regarding fiscal matters to: Annette Hanapole Grants Management Specialist Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room (insert), MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 402-5937 Fax: (301) 480-3780 E-mail: AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.8__(Use appropriate program number. NIAID citations are Sec. 93.856, Microbiology and Infectious Diseases Research, and No. 93.855 - Immunology, Allergy, and Transplantation Research.) Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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