PA-00-080: MOLECULAR EPIDEMIOLOGY OF PROSTATE CARCINOGENESIS

Department of Health
and Human Services (HHS)

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MOLECULAR EPIDEMIOLOGY OF PROSTATE CARCINOGENESIS Release Date: March 23, 2000 PA Number: PA-00-080 National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Environmental Health Sciences THIS PA 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 PA. This Program Announcement (PA) replaces PA-99-055, which was published in the NIH Guide on January 29, 1999. PURPOSE The National Cancer Institute (Divisions of Cancer Control and Population Sciences, Cancer Prevention, and Cancer Biology), the National Institute of Diabetes and Digestive and Kidney Diseases (Division of Kidney, Urologic, and Hematologic Diseases), and the National Institute of Environmental Health Sciences (Division of Extramural Research and Training) invite investigator-initiated research grant applications of molecular epidemiologic studies for advancement in understanding prostate cancer development and progression. The purpose of this initiative is to stimulate development and application of biological markers of prostate cancer risk and tumor aggressiveness and for utilization in chemoprevention studies. Of special interest are studies of markers to elucidate multiethnic differences in prostate cancer susceptibility. This PA will expire in two years from the first receipt date. NIH Grants policies apply to these awards. 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 area of cancer. This PA, Molecular Epidemiology of Prostate Cancinogenesis, is related the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) individual research project grants (R01). Responsibility for the planning, directing, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed 4 years. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will also vary. 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 http://grants.nih.gov/grants/funding/modular/modular.htm RESEARCH OBJECTIVES Background In the United States, prostate cancer has become the most frequently diagnosed neoplasm and the second leading cause of cancer mortality in men after lung cancer (SEER Prostate Cancer Trends, 1973-95 at http://seer.cancer.gov/Publications/ProstMono/). Its incidence rate has continued to increase rapidly during the past two decades, especially in men over the age of 50 years, and 184,500 new incident cases are expected to be diagnosed in 1998. Prostate cancer develops more rapidly with advancing age than any other form of cancer and with the present trend toward an aging population, its impact is a major public health concern. The etiology of prostate cancer is obscure. Clues may be derived from descriptive epidemiology characterizing the steep slope of incidence with advancing years, variation in race-specific and international incidence patterns, and high prevalence of latent (clinically silent and histologically apparent) carcinoma. The most compelling hypothesis supports a hormonal etiology based on the androgen-dependency of the prostate gland for growth and function. Studies in animal models have demonstrated the role of androgens in the induction of prostate cancer. Moreover, in humans, men castrated before puberty do not develop prostate cancer, and prostate cancer has responded to estrogen therapy. Case-control studies of serum testosterone and other hormones have thus far, however, reported inconsistent results, although it has been reported that populations with high levels of serum testosterone have an increased incidence of prostate cancer. Past studies of familial aggregation and genetic analyses have indicated a heritable component in risk. Recent investigations have suggested that prostate cancer risk is related to certain polymorphic genes that regulate androgen metabolism, particularly the androgen receptor (AR) gene, and the steroid 5-alpha-reductase type II (SRD5A2) gene. In addition, there has been interest in the cytochrome p450c17alpha (CYP17) gene, which encodes the enzyme involved in testosterone biosynthesis, and the 3beta-hydroxysteroid dehydrogenase type II (HSD3beta2) gene which encodes enzymes involved in metabolism of dihydrotestosterone. Furthermore, there is some evidence relating hereditary prostate cancer to loci on chromosomes 1q and chromosome X, while some cases appear to arise in association with familial breast cancer in relation to BRCA1 and 2. The consistently wide geographic variation in rates as well as results of migrant studies suggest a role for environmental factors, including diet and nutrition. African American men have the highest incidence and mortality rates in the world, almost 1.5 times higher than among U.S. whites and much higher than among African populations. The incidence varies widely around the world: a 65-fold difference exists between countries with the highest (blacks in U.S. SEER: 137 per 100,000) and lowest (Shanghai, China: 2 per 100,000) incidence rates of prostate cancer. In addition, immigrants from low-risk countries (e.g., China or Japan) experience an increased risk after migrating to a high-risk country (e.g., United States). Evidence from case-control and cohort studies has suggested that dietary fat may be associated with invasive prostate cancer while certain micronutrients such as vitamin D, vitamin E, and selenium may be protective. The role of other environmental exposures (e.g., occupation, ionizing radiation, viruses) is inconclusive while the effects of lifestyle factors (e.g., smoking, alcohol consumption, sexual behavior, body mass, physical activity, vasectomy) have yet to be clarified. The special characteristic of latent prostatic tumors, detected most often at autopsy and estimated to affect one third of all males older than 50 years, has remained an enigma in our understanding of the natural history and biology of invasive prostate cancer. Interestingly, there are no clear racial or geographic differences in the occurrence of small intraprostatic foci of latent cancer, whereas the prevalence of larger focal lesions parallels the variations in mortality rates. It has been hypothesized that environmental factors may affect the transition of latent to invasive cancer by acting as tumor promoters. Little is known about the molecular events and processes involved in the progressive transition to invasive cancer. Although genetic alterations in several chromosomes (e.g., 5, 8, 10, 16, 17, 18, and 22) have been reported in relation to prostate carcinogenesis, the association with tumor initiation and progression remains to be elucidated. Research Goals and Scope The purpose of this initiative is to stimulate innovative molecular epidemiologic research into the origins and progression of prostate cancer. Interdisciplinary collaborations, which may include multicenter study sites as well as joint effort between NIH/NCI intramural and extramural scientists, are encouraged. These collaborations may include utilization of shared laboratory and specimen resources whenever possible. Applications will be welcomed from investigators who are participating in ongoing collaborative organizations such as the George M. O"Brien Kidney and Urologic Research Centers, the Specialized Programs of Research Excellence in Prostate Cancer (SPORES), the NIEHS Environmental Health Sciences Centers and the General Clinical Research Centers (GCRCs). Proposed research duplicating that which is currently supported should not be submitted. Proposals to expand an ongoing epidemiologic study by the addition of a laboratory component will be considered. Transitional molecular epidemiology studies characterizing and validating biomarkers while determining optimal biological specimens and the most suitable procedures for collection, processing, and storage are encouraged. Selected measurements or biomarkers should be relevant to the processes of prostate carcinogenesis. Additionally, the utility of hormonal and surrogate or intermediate biomarkers should be demonstrated with an evaluation of sensitivity, specificity, intra- and inter-individual variability. Investigations in understudied populations and in populations of contrasting risk, including those who are residing outside of the U.S., are strongly encouraged. Establishment of cohorts of young and older men for participation in longitudinal studies as well as of resources such as germline DNA repositories and tumor tissue banks with clinical and epidemiologic databases is highly recommended. There is continued interest in ascertainment of high-risk families, particularly African-American, to accelerate gene identification and functional research. This PA invites a range of interdisciplinary investigations, including molecular epidemiologic, family, or population-based studies of prostate cancer, utilizing available or new/novel biomarkers (e.g., biochemical, molecular, cellular, genetic) and sources of specimens (e.g., prostate tissue, prostatic fluid, blood components) whenever possible. Examples of topics of interest to the participating NIH institutes include, BUT ARE NOT LIMITED TO, the areas listed below. I. NCI (in response to relevant recommendations of the NCI Prostate Cancer Review Group, a committee of members of the scientific, medical, industrial, and advocacy communities with the goal of developing a national plan for pursuing scientific opportunities in prostate cancer research, refer to URL address: http://www.nci.nih.gov under "What’s New") o Etiology and tumor progression - differences in genetic predisposition due to variations (polymorphisms) in susceptibility and low-penetrance genes, DNA repair activities, cell cycle progression, chromosome sensitivity to mutagens or in hormonal metabolism - gene-environment interactions for understanding modification of prostate cancer risk and influence on tumor progression - suspected premalignant processes (e.g., morphological changes) as independent or joint risk factors with, for example, hormones, nutrition, genetic components, exogenous exposures that contribute to the transition from latent to invasive cancer - biologic characteristics in pre-cancerous lesions and tumor, such as malignancy associated changes, heterogeneity or clusters of small foci, that can better define the natural history of prostate cancer and predict prognosis o Biomarkers - assessment and validation of genetic and epigenetic markers that predict tumor progression from localized to disseminated prostate cancer - validation of existing biomarkers of risk (e.g., androgen receptor mutations, 5-alpha-reductase isoenzymes, epithelial cell receptors, hormonal panels including insulin growth factor) in human populations with simultaneous consideration of biological variables (e.g., age, ethnicity, genetic predisposition, hormonal profiles, pre-existing disease) and lifestyle risk factors - identification, assessment, and validation of novel biomarkers for early detection and diagnosis, including comparison with current indicators such as PSA - development and clinical validation of new biological markers associated with prostate cancer biology (e.g., apoptosis, cell cycle control) with determination of their role in responses to specific forms of systemic therapy - development and validation of surrogate markers (e.g., nuclear chromatin texture as quantitated by image analysis) that can serve as intermediate endpoints for intervention or clinical trials testing preventive modalities o Diet and lifestyle factors - identification of dietary nutrients affecting prostate cancer risk and mechanisms of action by which risk is altered - pilot intervention studies of dietary nutrients (e.g., phytoestrogens, micronutrients such as vitamins D and E, lycopene, selenium) - role of lifestyle factors (e.g., smoking, alcohol intake), occupational and environmental exposures (e.g., pesticides, viruses), sexual behavior, anthropometry - effect of dietary intake (e.g., fat, micronutrients such as vitamin D, calcium, beta-carotene) singly and jointly or interacting with endogenous parameters (e.g., growth factors, steroid receptors, androgen conjugates) o Primary prevention - evaluation, including mechanisms of action and affected stages of carcinogenesis and inhibition, of promising preventive agents based on selection of tumor characteristics most amenable to preventive strategies - identification and characterization of suspected premalignant processes (e.g., prostatic intraepithelial neoplasia or PIN, dysplasia, atypical adenomatous hyperplasia) as potential intermediate markers for intervention trials II. NIDDK o Identification of risk factors (e.g., environmental, hormonal, viral exposure, sexually transmitted diseases, lifestyle, ethnicity) associated with benign prostatic hyperplasia or chronic prostatitis and clarification of their possible relationships to the development of prostate cancer III. NIEHS (reflecting the January 1998 announcement of the Environmental Genome Project (EGP) to understand the role of environmental response genes on human susceptibility to environmental agents, extensive background information on the EGP is available at the following URL: http://www.niehs.nih.gov/envgenom o Elucidation of the role of environmental response genes (e.g., genes which control the distribution and metabolism of toxicants, genes for DNA repair pathways, genes for cell death and differentiation, receptor genes, etc.) in the development of prostate cancer o Enhanced understanding of the impact of occupational and environmental exposures on the risk of prostate cancer including interactions with genetic factors o Exploration and elucidation of the role of timing of environmental exposures during critical periods of normal prostate gland development (e.g., fetal period, childhood, puberty) relevant to future risk of carcinogenesis including, but not limited to: (a) cellular, genetic, and hormonal effects of environmental exposures on normal and abnormal prostate growth and development, and (b) mechanisms by which environmental exposures acting as initiating or promoting agents at various time periods affect the risk and latency of prostate cancer SPECIAL REQUIREMENTS Awardees under this PA are strongly encouraged to participate in a one-day meeting of investigators to be held in Bethesda, Maryland, during the last year of the grant. Program directors from the NCI, NIDDK, and NIEHS will coordinate this meeting which will provide the opportunity for principal investigators to discuss their proposals and work in progress as well as any cross-disciplinary methodological and scientific issues. Applicants may request sufficient funds in the budget to accommodate expenses for one to two participants to attend the meeting. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is 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 "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994 available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html Applications received in response to this PA are expected to focus on scientific issues related to prostate cancer. In describing the plan to recruit human subjects, investigators may cite a focus on prostate cancer as the justification for why women will be excluded. In this regard applicants may use Justification 1 from the policy announcement: the research topic to be studied is irrelevant to women. 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/or 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 "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 is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Applications received in response to this PA are expected to focus on scientific issues related to prostate cancer. In describing the plan to recruit human subjects, investigators may cite a focus on prostate cancer as the justification for why children will be excluded. In this regard applicants may use Justification 1 from the policy announcement: the research topic to be studied is irrelevant to children. APPLICATION PROCEDURES The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. 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: grantsinfo@nih.gov. For applicants with Internet access, the 398 kit may be found at: http://grants.nih.gov/grants/forms.htm The PA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Applicants are strongly encouraged to call the program contacts listed in INQUIRIES below with any questions regarding responsiveness of their proposed project to the goals of this PA. SPECIAL INSTRUCTIONS FOR MODULAR GRANT APPLICATION PROCEDURES 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: o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments) 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 NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative page (see http://grants.nih.gov/grants/funding/modular/modular.htm 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, list key project personnel, including their names, percent of effort, and roles on the project. 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 and organizations with whom consortium and contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is domestic or foreign. The total cost for a consortium/ contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. 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, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm -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. CHECKLIST: This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be identified and applied in the calculation of the F&A costs for the initial budget period and all future budget years. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the Institute staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. 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. Submit a signed, typewritten original of the application, including the checklist, and five 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/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. 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 applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. 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. Each of these criteria will be addressed and considered 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 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 method? 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? The initial review group will also examine: the appropriateness of the proposed project budget and duration, the adequacy of plans to include minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the adequacy of plans to include children as appropriate for the scientific goals of the research, or justification for exclusion, the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. NCI intends to additionally consider meritorious applications responding to this PA for funding by exception. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and Institute/program priorities. INQUIRIES Inquiries concerning this PA are encouraged, particularly during the planning phase of the grant applications. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Kumiko Iwamoto National Cancer Institute Executive Plaza North, Suite 535 Bethesda, MD 20892-7395 Telephone: (301) 435-4911 FAX: (301) 402-4279 Email: ki6n@nih.gov Dr. Leroy Nyberg National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS-13G Bethesda, MD 20892 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: nybergl@extra.niddk.nih.gov Dr. Gwen W. Collman National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4980 FAX: (919) 541-4937 Email: collman@niehs.nih.gov Direct inquiries regarding fiscal matters to: William Wells Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-8796 FAX: (301) 496-8601 Email: wellsw@gab.nci.nih.gov Trude McCain Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, 6AN-44J Bethesda, MD 20892 Telephone: (301) 594-8859 FAX: (301) 480-4237 Email: hilliardt@extra.niddk.nih.gov Dorothy G. Duke Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-2749 FAX: (919) 541-2860 Email: duke3@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393, 93.849, and 93.894. 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 Part 74 and 92. This program is not subject to intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients 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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