and Human Services (HHS)
EXPIRED
BASIC RESEARCH IN THE BLADDER AND LOWER URINARY TRACT RELEASE DATE: June 9, 2003 PA NUMBER: PA-03-136 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Replacement R01 (PA-06-254) and R21 (PA-06-255) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE: After October 1, 2005, unless reissued. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) National Institute of Aging (NIA) (http://www.nia.nih.gov) Office of Research on Women's Health (ORWH) (http://www4.od.nih.gov/orwh/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.849, 93.866 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute on Aging (NIA), in cooperation with the National Institutes of Health (NIH) Office of Research on Women's Health (ORWH), invite applications for research studies which focus on basic cellular, molecular, genetic and developmental mechanisms of the normal and abnormal function of the bladder and lower urinary tract. An important goal of this initiative is to attract new and established investigators from a variety of basic science research areas to apply their knowledge, skills, and tools to studies of the bladder and lower urinary tract. Areas of special interest include, but are not restricted to, basic cellular biology of bladder epithelial and smooth muscle cells and connective tissues; organ innervation, vascularization and physiology; genomics and proteomics, including studies of age-related changes in gene expression; development of animal models; pathogen-host interactions in infectious conditions of the bladder; and developmental biology of the lower urinary tract including sex differences. Studies proposing the development and application of novel tools and technologies including methods of in vivo functional assessment and imaging are encouraged. Also, basic science studies addressing sex/gender differences that may predispose women to bladder and lower urinary tract disorders are encouraged. Another important goal is to promote productive research collaborations for study of the lower urinary tract between clinicians and basic scientists. This Program Announcement (PA) is presented as part of the ongoing commitment of the NIDDK, NIA, and ORWH to biomedical research aimed at improving bladder and lower urinary tract health. RESEARCH OBJECTIVES A. Background Disorders of the urinary bladder and associated structures including urinary incontinence, chronic pelvic pain, urinary tract infections (UTIs), interstitial cystitis (IC), vesicoureteral reflux, and dysfunctional bladder emptying are a major cause of morbidity and impaired quality of life. As many as 35 million Americans are estimated to suffer from disorders and diseases of the bladder, with bladder disease affecting all ages, races, and ethnic groups. While bladder and urinary tract illness affects both genders, women are the primary victims of urinary incontinence, IC, and UTIs, as well as other diseases of the urinary system. In addition, many disorders of the bladder, such as urinary incontinence, change with age. Disordered bladder function is a common complication of diabetes. While some progress has been made in the diagnosis, management, and treatment of diseases of the bladder and lower urinary tract disease, these problems frequently remain intractable. This initiative is undertaken with the expectation that improved bladder health will eventually result from better understanding of the basic biology of these organs under normal and pathological conditions. The goal of the NIDDK, NIA, and ORWH in developing this PA is to promote high-quality, basic research that will lead to important discoveries relevant to bladder and lower urinary tract biology. It is anticipated these discoveries will aid future development of predictive early markers of disease, preventive measures, and more effective treatments for a wide range of bladder and lower urinary tract conditions and diseases. Achieving the goals outlined in this PA was deemed a high-priority by the Bladder Research Progress Review Group (http://www.niddk.nih.gov/fund/other/bladderprg_web/index.html) and the ORWH (http://www4.od.nih.gov/orwh/FY03Priorities.pdf. B. Objectives and Scope This PA encourages basic cellular, molecular, developmental and genetic research relevant to the bladder and lower urinary tract. Basic research studies that address age and gender differences in bladder and lower urinary tract function are also encouraged. New and established investigators from related fields of study are encouraged to apply their expertise to these problem areas. Investigators with diverse basic science and clinical backgrounds are encouraged to develop collaborative research relationships. Discoveries resulting from these studies may serve as the basis for the development of new agents, techniques, and strategies for detecting, preventing, and treating diseases of the bladder and lower urinary tract, as well as dealing with bladder complications resulting from other diseases, such as diabetes. Basic research in the following areas are examples of areas of high interest: o Epithelial cell biology, including function, growth, and differentiation of bladder urothelium; interactions of epithelium with mesenchyme; and the cellular and molecular basis for epithelial dysfunction in disease. o Smooth muscle cell biology, including neuromodulation and neuronal characteristics of bladder smooth muscle, smooth muscle receptor and cell- signaling mechanisms, as well as studies addressing bladder striated muscle and detrusor biology. o Developmental biology, including the biology and genetics of early organogenesis and lower genitourinary tract development and dysfunction in children. o Studies of bladder innervation, including the developmental biology of organ innervation, studies of motor and sensory neurophysiology, imaging methods to assess organ innervation and studies of pain modulation in the bladder and pelvis. o Connective tissue research, including cell-extracellular matrix relationships in cell signaling and overall bladder function, deposition of matrix components, and the role of connective tissues in bladder regeneration. o Molecular genetics, including identification of genetic mutations affecting bladder and lower urinary tract function and susceptibility to disease. o Development of animal models for basic science analyses of bladder and lower urinary tract function in vivo. o Immunology, including immune responses of the bladder and autoimmunity as a potential causal factor in bladder disease. o Host-pathogen interactions in urinary tract infections and latent infections and the role of latent infections as a potential causal factor in bladder disease. o Genomics and proteomics approaches to bladder biology and disease, including identification of disease markers (i.e. biomarkers) and genomic changes useful for prediction and diagnosis of disease or response to therapy. o Development and application of new and novel basic and clinical technologies, including cell and molecular imaging and techniques to separate and analyze individual, physiological relevant cell types and methods to study bladder function in vivo and to image whole organ function. o Molecular and cellular studies of bladder and lower urinary tract tissues that demonstrate how age related changes impact on the function of these tissues. MECHANISM(S) OF SUPPORT This PA will use the National Institutes of Health R01 (Research Project) and R21 (Exploratory/Development Project) award mechanisms (for a description of R01 and R21 awards see http://www.niddk.nih.gov/fund/grants_process/revmech.htm). The R01 award represents an investigator-initiated research grant designed to support a discrete, specified research project performed by a principal investigator. R01 applications awarded through this PA will provide funds for a maximum period of five years and are renewable. The R21 award represents an exploratory/developmental research grant for support of high-risk pilot and feasibility research designed to develop new ideas sufficiently to allow future submission of a full R01 application. R21 grants awarded through this PA will provide up to $275,000 for the two year period. No more than $200,000 may be requested in any single year. The request should be tailored to the needs of the project. Applicants are solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. For applications with direct costs exceeding $250,000 follow the PHS 398 instructions for non-modular research grant applications. ELIGIBLE INSTITUTIONSYou 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 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 DATA SHARING: Data sharing achieves many important goals for the scientific community, such as reinforcing open scientific inquiry, encouraging diversity of analysis and opinion, promoting new research, testing of new or alternative hypotheses and methods of analysis, supporting studies on data collection methods and measurement, facilitating teaching of new researchers, enabling the exploration of topics not envisioned by the initial investigators, and permitting the creation of new data sets by combing data from multiple sources. Applications submitted in response to this PA must include a data sharing plan in the application. This plan will be reviewed for: 1) statements of willingness to share information fully; 2) adequate and clear strategies for sharing results, data, tools, and mice with the research community and/or websites maintained by the NIH; and 3) non-restrictive nature of included Material Transfer Agreements and Mouse Transfer Agreements In their applications investigators must acknowledge their willingness to fulfill these requirements. Additional, information regarding data sharing may be found at: http://grants.nih.gov/grants/policy/data_sharing/index.htm WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues. o Direct your questions about scientific/research issues to: Chris Mullins, Ph.D. Director, Basic Cell Biology Programs National Institute of Diabetes, Digestive and Kidney Diseases 6707 Democracy Blvd., Room 637 Bethesda, MD. 20892-5458 Telephone: (301) 594-7717 FAX: (301) 480-3510 E-mail: mullinsc@extra.niddk.nih.gov Leroy M. Nyberg, Jr., Ph.D., M.D. Director, Urology Programs National Institute of Diabetes, Digestive and Kidney Diseases 6707 Democracy Blvd., Room 627 Bethesda, MD. 20892-5458 Telephone: (301) 594-7717 FAX: (301) 480-3510 E-mail: nybergl@extra.niddk.nih.gov Frank Bellino, PhD Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: bellinof@nia.nih.gov Lisa Begg, Dr.P.H., R.N. Director of Research Programs Office of Research on Women's Health Office of the NIH Director National Institutes of Health/DHHS Telephone: (301)496-7853 Fax: (301)402-1798 E-mail: beggl@od.nih.gov o Direct your questions about financial or grants management matters to: Ms. Trude Hilliard Grants Management Specialist National Institute of Diabetes, Digestive and Kidney Diseases 6707 Democracy Blvd., Room 717 Bethesda, MD. 20892 Telephone: (301) 594-8859 FAX: (301) 480-3504 E-mail: hilliardt@extra.niddk.nih.gov Ms. Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301)496-1472 FAX: (301)402-3672 Email: WhippL@gw.nia.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. 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 http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: o Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; o Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, o Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by an appropriate 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: o Significance o Approach o Innovation o Investigator o Environment 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. 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 will be assessed. 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 CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program 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. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD- 02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001 .htm. 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 http://grants.nih.gov/grants/funding/children/children.htm. 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. 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 (http://www.hhs.gov/ocr/) 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ 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 http://grants.nih.gov/grants/policy/policy.htm. 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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