HUMAN EMBRYONIC STEM CELL RESEARCH RESOURCE INFRASTRUCTURE ENHANCEMENT AWARD RELEASE DATE: September 26, 2003 PAR NUMBER: PAR-03-177 (see addenda NOT-AI-04-012 and NOT-HL-04-102) EXPIRATION DATE: January 12, 2005, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) National Institute on Aging (NIA) (http://www.nia.nih.gov) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.389, 93.847, 93.865, 93.848, 93.849, 93.866. LETTER OF INTENT RECEIPT DATES: December 14, 2003, December 12, 2004 APPLICATION RECEIPT DATES: January 14, 2004, January 12, 2005 THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of this PAR o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Supplementary Instructions o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PAR The purpose of this initiative is to enhance the availability of human embryonic stem cells (hESC) for research. The research projects proposed under this Program Announcement (PAR) will address the expansion, testing, quality assurance, cryopreservation and distribution of existing hESC lines that are in compliance with criteria for federal funding of research on existing hESC as described in http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. RESEARCH OBJECTIVES Background Embryonic stem cells uniquely proliferate in an undifferentiated state while retaining the capability to develop into the cell types derived from all three germ layers. Research suggests that mammalian embryonic stem cells have a potential for directed development that might allow for the replacement, or restoration, of cell and organ function. The recent development of hESC has been greeted as a first step in a process that holds promise for the restoration of cell or organ function in man. Substantial basic research on the characterization, mechanisms of differentiation, and regulation of cellular processes of hESC is essential before their potential in medicine can be assessed. This basic research requires supplies of cells that meet quality controls and behave reproducibly. The cells will need to be available in sufficient quantity for research and testing in multiple laboratories. hESC that are acceptable for research purposes are listed in the NIH Human Embryonic Stem Cell Registry http://escr.nih.gov. This initiative aims to enhance the availability of hESC for preclinical investigations. The development of quality controls to monitor the laboratory performance of the hESC lines is an integral part of the initiative. Scope of the Activity Costs allowed under this initiative will include: o Rental fees for laboratory space to support the expansion of existing hESC lines in compliance with good laboratory practices (GLPs) (21 CFR part 58). o Personnel costs for laboratory supervision and the maintenance of GLP cell culture procedures. Training of new laboratory technicians is allowed for the purposes of increasing skill levels to culture hESC lines. o Equipment needed for the expansion, quality assurance, storage, and distribution of hESC and feeder lines. o Cell culture supplies including media, plates, flasks, growth factors and other nutrients, cell freezing, disposal, storage, and distribution materials. o Travel for the quality control certification of reagent vendors. o Development and support of a website that will make available information concerning the availability and properties of cell lines. Costs not allowed under this initiative: o Renovation, acquisition or building of facilities. Activities that are encouraged under this initiative include: o Culture of existing cells sufficient to support the distribution of 100 or more aliquots of two million cells for each supported line per year for three years. o Establishing the viability of existing cell cultures, performing initial expansion and characterization to ensure sufficient numbers of cells in preparation of scale-up and distribution of cells. o Characterization of hESC by cell surface markers, DNA fingerprinting, and transcriptional profiling. o Karyotype, telomere, and fluorescent in-situ hybridization studies of cells at various passages. o Maintenance of frozen primary cell culture and "freeze-backs" from successive passages. o Development of sub-lines at various passages. o Development of cryopreservation techniques. o Xenografts into experimental animals to characterize hESC cell differentiation capabilities. o Quality assurance measures including studies of functionality after multiple freeze/thaw cycles, and sterility testing. o Development of technical support materials for researchers including laboratory instruction manuals and audio-visual resources. o Establishment of web-based instructional materials that describe the biological features of hESC. o Identification of optimal culture materials and conditions to maintain and expand hESC. This could include the development of human feeder cells, extracellular matrix substrates and/or serum-free or serum substituted culture conditions. o Development of culture supplies or cell culture kits to accompany the cells upon distribution to researchers. This may be achieved via sub-contracts with commercial suppliers of such materials. o Development of a plan for cost recovery for resources supplied. Activities that are beyond the scope of this initiative and prohibited from support from this grant award include: o Derivation of new human embryonic stem cell lines from human blastocysts. o Research and development of stem cells from animals or other human sources. o Research to differentiate hESC. o Basic research on fundamental cellular and molecular mechanisms. o Animal transplantation studies with the exception of those described above. MECHANISM OF SUPPORT This PAR will use both the National Institutes of Health (NIH) Resource- Related Research Projects (R24) award mechanism and the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The SBIR and STTR applications received in response to this announcement will be considered for both Phase I and Phase II support. This PAR must be read in conjunction with the Omnibus Solicitation of the Public Health Service for Phase I SBIR Grant Applications found at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf and the instructions for Phase II Grant Applications found at http://grants.nih.gov/grants/funding/sbir.htm#sol. The R24, SBIR and STTR mechanisms may be used to support research projects that will enhance the capability of resources to serve biomedical research. Direct costs of awards made under the R24 mechanism are limited to $300,000 per year for each of the planned three years of support. Grants under the SBIR and STTR mechanisms may reach $750,000/year. Funding for the next year will be contingent on satisfactory progress during previous years of the award. The total project period for an application submitted in response to this PAR may not exceed three years. This PAR may be reissued or additional PARs or Requests for Applications may be available in FY 2006 pending the availability of funds. 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 Special eligibility requirements for SBIR and STTR applications may be found at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf and http://grants.nih.gov/grants/funding/sbir.htm#sol. 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 Applicants must have hESC lines listed on the NIH Human Embryonic Stem Cell Registry, http://escr.nih.gov. For SBIR/STTR support, only institutions or organizations based in the United States with eligible hESC, or their affiliates, are eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Applicants are advised to budget for travel to attend an annual 2-day scientific and technical meeting in Bethesda, MD. In addition, competing continuing (renewal) applications must give evidence at the time of submission that registered cell lines have been developed to a degree that allows for their immediate distribution. SBIR/STTR applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. Details of the NIH data sharing requirements may be found at: http://grants.nih.gov/grants/policy/data_sharing/). Each quarter, infrastructure awardees must report the number of orders for each approved hESC line received, together with the number of orders shipped. Additionally, the number and domestic/foreign status of recipients must also be reported. Where possible, the NIH funding status of the recipients should be disclosed. Electronic copies of web-based instructional materials that describe the biological features of hESC and other training materials should be made available for posting on the NIH Stem Cell web site. WHERE TO SEND INQUIRIES We encourage inquiries concerning this PAR 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: L. Tony Beck, Ph.D. Program Officer, Division of Clinical Research National Center for Research Resources 6701 Democracy Boulevard, Room 916, MSC 4874 Bethesda, MD 20892-4874 Telephone: (301) 435-0805 FAX: (301) 480-3661 Email: beckl@mail.nih.gov o Direct your questions about peer review issues to: John F. Connaughton, Ph.D. Scientific Review Administrator National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Blvd, Room 757, MSC 5452 Bethesda, MD 20892-5452 For courier services (FEDEX), use Zip Code 20817 Phone: 301-594-7797 FAX: 301-480-3505 email: connaughtonj@extra.niddk.nih.gov o Direct your questions about financial or grants management matters to: Ms. Mary Niemiec Section Grants Management Officer Office of Grants Management National Center for Research Resources 6701 Democracy Boulevard, Room 1046, MSC 4874 Bethesda, MD 20892-4874Bethesda, MD 20892-4874 Telephone: (301) 435-0842 FAX: (301) 480-3777 Email: maryn@mail.nih.gov 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 PAR Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: John F. Connaughton, Ph.D. Scientific Review Administrator National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Blvd, Room 757, MSC 5452 Bethesda, MD 20892-5452 For courier services (FEDEX), use Zip Code 20817 Phone: 301-594-7797 FAX: 301-480-3505 email: connaughtonj@extra.niddk.nih.gov 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 http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. 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) 435-0714, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement must be received on or before January 14, 2004 or January 12, 2005. SBIR/STTR applicants for Human Embryonic Stem Cell Research Resource Infrastructure Enhancement Awards should also use these dates. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: John F. Connaughton, Ph.D. Scientific Review Administrator National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Blvd, Room 757, MSC 5452 Bethesda, MD 20892-5452 For courier services (FEDEX), use Zip Code 20817 Phone: 301-594-7797 FAX: 301-480-3505 email: connaughtonj@extra.niddk.nih.gov APPLICATION PROCESSING: Applications must be received on or before January 14, 2004 or January 12, 2005. The CSR will not accept any application in response to this PAR 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 unfunded version 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 PAR will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o 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 written critique o 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 evaluate each 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 the following 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 the proposed work enhance research resources for hESC? APPROACH: Are the plans for hESC production, characterization and quality control adequately developed, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the timeline for the proposed projects reasonable? INNOVATION: Will the project provide improved methodologies, knowledge or training opportunities to facilitate researcher use of hESC lines? INVESTIGATOR: Are the investigator and key personnel sufficiently knowledgeable, experienced, and 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? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: Additional criteria for competing continuation (renewal) applications include the progress and achievements specific to this project since the previous competing review. The application should show that the previous specific aims have been accomplished and that the new goals are logical extensions of ongoing work. The reviewers will provide an administrative comment evaluating the adequacy and feasibility of the resource sharing plan. Recommendations regarding such plans are at http://www.ott.nih.gov/policy/rt_guide_final.html. This comment will not affect the priority score of the proposal. NIH staff will consider the adequacy of the plan in determining whether to recommend an application for award. The sharing plan as approved, after negotiation with the applicant as necessary, will become a condition of the grant award. SBIR/STTR Review Criteria include the significance of the proposed project as assessed by the ability to lead to a marketable product or process. Applicants should refer to the SBIR/STTR review criteria at: http://grants.nih.gov/grants/funding/sbirsttr_ReviewCriteria.htm. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of the proposed protection for laboratory staff working with the cells, animals or the environment, to the extent they may be adversely affected by the activities proposed in the application. 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. 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 Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. 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 PAR 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. SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be provided through these infrastructure awards. 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 PAR 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 PAR is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. 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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