AIDS-RELATED ORAL MALIGNANCIES AND TUMORS RELEASE DATE: October 31, 2003 RFA Number: RFA-DE-05-001 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Dental and Craniofacial Research (NIDCR) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): No. 93.121, Oral Diseases and Disorders Research LETTER OF INTENT RECEIPT DATE: May 18, 2004 APPLICATION RECEIPT DATE: June 16, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of This RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this initiative is to stimulate research that will improve our understanding of the biological basis of development and progression of AIDS-related oral cancers and tumors, and to encourage research identifying novel targets for treatment, and biomarkers for early diagnosis and monitoring of disease progression. The role of chronic latent viruses of the oral cavity and their interaction with one another or with environmental factors in the context of HIV infection leading to the development of tumors or lesions with oncogenic potential is especially sought. RESEARCH OBJECTIVES Background HIV infection is a major public health problem throughout the world. The hallmark of this infection is a gradual depletion of CD 4+ T cells which eventually leads to a state of immunosuppression. This immunosuppression predisposes the patients to warts, preneoplastic oral lesions and oral cancers. Some of these neoplasms are aggressive, hard to treat and can affect the quality of life of the patients. Oral malignancies and tumors affect up to 25% of patients with AIDS. The most frequent oral malignancies are Kaposi’s sarcoma (KS) and non- Hodgkin’s lymphoma. Oral warts and oral hairy leukoplakia (OHL), a benign epithelial hyperplasia of the lingual squamous epithelium, have also been shown to increase among patients with HIV infection. The incidence of some of these conditions has changed following the introduction of highly active antiretroviral therapy (HAART). For example, the incidence of KS has significantly decreased, while plasmablastic lymphoma has increased. The latter is a diffuse large B- cell lymphoma with a unique immunophenotype and appears to be associated with Epstein Barr virus (EBV). EBV is also associated with OHL and nasopharyngeal carcinoma. Human papillomavirus (HPV), another DNA virus, has been associated with the development of oral warts. The incidence of these warts appears to be increasing in the HAART era. Occasionally the oral warts in HIV infected patients show marked epithelial dysplasia. Recently the presence of HPV 16 and 18 in oral warts of some AIDS patients has been reported. HPV 16 has previously been implicated in invasive squamous cell carcinoma of the head and neck. However, until the patients are followed for an extended period of time, the risk for development of squamous cell carcinomas from oral dysplastic warts will remain unknown. The biological basis for AIDS-related oral lesions is not yet clear. There appears to be an emerging role for various concurrent viral infections in the HIV-infected host that are likely implicated in the pathogenesis of these ailments. For the purpose of this RFA the oral lesions of interest are the ones associated with concomitant infection with viruses that frequently confer latency, such as EBV, human herpesvirus 8 and HPV. In each case, the infection by each concomitant virus appears to be necessary, but not sufficient, for subsequent tumor development. Interestingly, the genomes of some of the viruses that are associated with the oral complications of HIV infection have sequence homology with some human cytokines and/or chemokines. For example, cytomegalovirus encodes vIL10 and CXC1&2, EBV encodes vIL10 and HHV-8 encodes vIL6. The role of this mimicry to cellular cytokines in disease pathogenesis is not known. IL10 and IL6 are known to mediate Th2 cell responses and to inhibit Th1 immune responses. IL6 is also known to stimulate lymphocyte proliferation. Patients with HIV-related salivary gland disease present with signs and symptoms similar to those of patients with Sj gren’s syndrome. The condition is characterized by lymphocytic infiltration of the salivary glands and lymphoepithelial cysts of the major salivary glands and is part of diffuse interstitial lymphocytosis syndrome. Occasionally, lymphomas may develop within the salivary glands. The search for an etiology for this disease has so far been inconclusive. The incidence of salivary gland disease among HIV infected patients appear to has increased following the introduction of HAART. The cause of this increase is not known at the present time. Scope The objective of this RFA is to encourage research on the mechanisms and factors involved in the initiation and progression of AIDS related oral malignancies, their detection and management. Multidisciplinary approaches and collaborations are encouraged. Examples of research responsive to this RFA are listed below but are by no means inclusive: o Studies to characterize the host genetic susceptibility to AIDS- related oral malignancies and tumors in patients with HIV infection. o Studies to determine the pathogenic mechanisms involved in EBV, HHV- 8, and HPV mediated tumor initiation and promotion of malignancies of the oral cavity. For example, the interaction of viral gene products with cellular factors involved in the regulation of the cell cycle. o Studies to determine the cellular proteome and transcriptome of virally-induced tumors of the oral cavity in the context of HIV infection. o Studies to determine the mode of entry, latency, reactivation and transformation of oncogenic viruses of mucosal cells of the oral cavity. o Studies to determine the interactions of HIV structural and non- structural proteins with oncogenic viruses and their role in potentiation of transformation. o Studies to identify novel molecular targets for therapeutic interventions for oral KS and non-Hodgkin’s lymphoma. o Studies to determine the immunological mechanisms that are involved in EBV, HPV and HHV-8 driven oral malignancies and tumors, in the context of HIV infection. o Studies to determine the effect of prolonged moderate immunosuppression or incomplete or failed responses to HAART on the development of oral malignancies and tumors. o Studies to determine the effect of the concomitant prolonged exposure of HIV infected patients to antiretroviral therapy and viruses with oncogenic potential on the development of AIDS-related oral malignancies and pre-neoplastic lesions. o Studies to determine the molecular epidemiology of the viral strains that are implicated in the promotion of AIDS-related malignant transformations of the oral cavity. o Development of animal and cell based models for AIDS-related oral malignancies. o Studies to determine the similarities and differences between AIDS- related tumors of the oral mucosa and other anatomical mucosal surfaces, e.g. vaginal and gastrointestinal. o Studies that are geared towards identifying reliable diagnostic and prognostic biomarkers, useful for detection of AIDS-related oral malignancies and their progression. MECHANISM OF SUPPORT This RFA will use NIH individual research project grant (R01) and the exploratory/development research grant (R21) award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at FUNDS AVAILABLE The NIDCR intends to commit approximately $2,000,000 total cost in FY 2005 to fund 6 to 8 new and/or competitive continuation grants in response to this RFA. An R01 applicant may request a project period of up to 4 years and a budget for direct costs of up to $499,999 per year. An R21 applicant may request a project period of up to two years with a combined budget for direct costs of up to $275,000 for the two year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. This R21 cap may be exceeded by $25,000, direct costs per year to accommodate the facilities and administrative (indirect) costs associated with collaborative research at another institution. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIDCR 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. ELIGIBLE INSTITUTIONS You may submit an application(s) 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 or foreign institutions/organizations 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 Grantees will meet annually at or near NIH, Bethesda, MD, to share results, to ensure that the NIDCR has a coherent view of the advances in the field, and to have an opportunity for collective problem solving among investigators. Applicants should budget for travel in their requested budget for the principal investigator and one additional young investigator to attend this annual meeting. 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: Mostafa Nokta, MD, PhD. Division of Basic and Translational Sciences National Institute of Dental and Craniofacial research Building 45, Room 4AN-18H 45 Center Drive Bethesda MD, 20892-6402 Telephone: (301) 594-7985 Fax (301) 480-8319 Email: o Direct your questions about peer review issues to: H. George Hausch, Ph.D. Division of Extramural Activities National Institute of Dental and Craniofacial Research Building 45, Room 4AN-44F 45 Center Drive Bethesda, MD 20892-6402 Telephone: (301) 594-2904 Fax: (301) 480-8303 Email: o Direct your questions about financial or grants management matters to: Mary Daley Grants Management Branch Division of Extramural Activities National Institute of Dental and Craniofacial Research 45 Center Drive MSC 6402 Building 45, Room 4AN-44B 45 Center Drive Bethesda, MD 20892-6402 Telephone: (301)-594-4808 Fax: (301)-480-3562 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 NIDCR 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 Dr. Hausch at the address listed above. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: SUPPLEMENTARY INSTRUCTIONS FOR R21 APPLICATIONS All application instructions outlined in the PHS 398 application kit are to be followed with the following modifications for R21 applications: 1. FACE PAGE, Item 6: Up to a total of two years of support may be requested. Total direct costs for the two years may not exceed $275,000. 2. RESEARCH PLAN: Items a-d may not exceed fifteen (15) pages, including tables and figures. The following information should be taken into account for items a, b and c: o Item a, SPECIFIC AIMS--The instructions for this section suggest that the applicant state "the hypotheses to be tested". Since some applications submitted in response to this RFA may also be design- or problem-driven (e.g., development of novel technologies), or need- driven (initial research to develop a body of data upon which future research will build), hypothesis testing per se may not be the driving force in developing such a proposal and, therefore, may not be applicable. The application should state the hypotheses, design, problem and/or need which will drive the proposed research. o Item b, BACKGROUND AND SIGNIFICANCE--In this section, it is important to identify clearly how the application addresses the specific objectives of this RFA and the purpose of the R21 mechanism. o Item c, PRELIMINARY STUDIES/PROGRESS REPORT No preliminary data are required for an R21 application. 3. APPENDIX. Up to five articles may be submitted as appendix materials. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at 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, original copy 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, send two additional copies of the application and all copies of the appendix material to: H. George Hausch, Ph.D. Division of Extramural Activities National Institute of Dental and Craniofacial Research Building 45, Room 4AN-44F 45 Center Drive Bethesda, MD 20892-6402 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: APPLICATION PROCESSING: Applications must be received on or before June 16, 2004. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCR. 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 NIDCR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by the NIDCR National Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 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? 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? 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? 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)? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. R21 APPLICATIONS: The potential for ground-breaking, precedent- setting research, with particular emphasis on novel and innovative approaches; and the potential to stimulate new concepts or approaches regarding important biomedical/behavioral problems, or provide a technique/system of wide applicability. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: May 18, 2004 Application Receipt Date: June 16, 2004 Peer Review Date: August 2004 Council Review: September/October 2004 Earliest Anticipated Start Date: December 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 HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety 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 "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, in the project description and elsewhere in the application as appropriate, 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 PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at 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 at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at 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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