COOPERATIVE CENTERS FOR TRANSLATIONAL RESEARCH ON HUMAN IMMUNOLOGY AND BIODEFENSE RELEASE DATE: September 16, 2002 RFA: AI-02-042 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) LETTER OF INTENT RECEIPT DATE: December 20, 2002 APPLICATION RECEIPT DATE: January 22, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Allergy and Infectious Diseases (NIAID) invites applications from single institutions or consortia of institutions to establish Cooperative Centers for Translational Research on Human Immunology and Biodefense. The long-term goal of this program is the translation of research using animal models of immunity to infection into clinical applications in humans. The immediate purpose is to support stable, flexible, centralized infrastructure and research needed to promote and coordinate multidisciplinary basic and clinical research in human immunology as it relates to defense against agents of bioterrorism and emerging/re-emerging infectious diseases. The program will be milestone-based, and will include the flexibility to quickly redirect or replace research projects during the funding period. Funding beyond the first year will be contingent upon satisfactory progress in meeting negotiated milestones. The Cooperative Agreement mechanism (U19), together with the Exploratory Planning Grant mechanism (R21), will be used to support the development of multi-investigator teams with a scope of activities not possible with other funding mechanisms. Each Center will consist of at least five components: (1) Research Resource Technical Development of assays, reagents, and technologies to advance more rapid and more definitive analyses of human immune responses, (2) a minimum of three Research Projects focused on understanding human immune response and regulation in the context of NIAID Category A-C pathogens or their products (see list at http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm),note that clinical trials, HIV research, and behavioral research will not be supported by this program, (3) Core Facilities to support the research projects or to facilitate management of the Center, (4) short-term Pilot Projects, and (5) an Education Component focused on short-term training in the technical or theoretical aspects of human immunology research and biodefense. Synergistic interaction is a key feature of this program. Each Center will provide unique and complementary strengths in terms of technical potential and specific areas of immunological investigation, and all Centers will share responsibility for program development and resource coordination via a Centers Steering Committee. Applicants must include research projects that address a central theme of immunological interest in the context of biodefense, as well as describe the unique technical expertise offered for the development and utilization of assays, reagents, and technologies. All applicants must comply with the requirements outlined in the section below entitled "SPECIAL REQUIREMENTS." RESEARCH OBJECTIVES Background The definitive study of immune response and regulation is much more difficult to achieve in humans than in animal model systems. Not only are experimental approaches limited, but genetic and environmental heterogeneity make it much more difficult to obtain reproducible results. Although many very talented and highly productive immunologists conduct animal studies that lead to rapid advances in fundamental knowledge and define tantalizing candidate approaches to the prevention or treatment of human disease, fewer researchers conduct immunological studies in the human. Many results obtained in animals do translate faithfully in the human, but some clearly do not. Therefore, research must also be conducted with human samples, to either verify findings or discover the relevant human pathways. A research program with a primary focus on infrastructure support for technology development and accessibility will help to open the bottleneck of human research and facilitate the translation of basic research into clinical applications. Human studies must be based on assays that can generate reproducible and meaningful data, and that can be used by many research groups to form a reliable foundation of knowledge. Therefore, new or improved technologies are needed to allow more definitive studies of immunological mechanisms, leading to more reliable clinical evaluation of disease progress, vaccine efficacy, or benefit of immune-based therapies. The scientific focus of this Centers program is immune biodefense against infectious pathogens and their products. Immune-based defenses against deliberately released or naturally occurring pathogens constitute very powerful weapons that complement drug-based approaches to control infectious disease. Safe and effective vaccine development will depend on better understanding of systemic and localized immune capacity, and of human variability at both the innate and adaptive levels of immunity and immunoregulation. Molecular mechanisms responsible for potent short-term immune responses and for long-term immune memory must be understood and optimized for new applications. Immune-based reagents, such as antibodies or defensins, should be developed for the passive protection of at-risk populations, and immune targets should be defined and tested to enhance immunomodulatory strategies. This program is expected to substantially support the biodefense effort by providing stable funding for immunology Centers focused on the translation from animal to human research. Research Objectives and Scope The ultimate goal of this program is to facilitate the discovery and translation of immunological knowledge into new strategies to prevent and treat infectious disease in humans. The immediate goals are to support (1) Research Resource Technical Development via sufficient infrastructure for the development of reagents, assays, and technologies for human immunology research, (2) a minimum of three Research Projects per Center focused on immunity to NIAID Category A-C pathogens or their products, (3) Core Facilities to enhance research activities, (4) Pilot Projects for innovative research, and (5) Education of research personnel in new technology or principles of human immunology. Each of these essential program components is discussed in more detail below. The approximate weight that each component should receive is indicated as a percentage of the annual direct costs to be proposed. These values are provided as guidance, significant exceptions may be proposed, but should be well justified. Components of the Center may be located solely at the parent institution or may be included through collaborative associations with investigators at other institutions. (1) Research Resource Technical Development Component (40%) Applications must include a dedicated component for the identification, validation, development, standardization, dissemination and/or economization of specialized assays, reagents, and technologies of use to the research community for human studies in immunology. Resource development may include, but is not limited to: improved high throughput rapid screening techniques, single cell assay development, improved assays of immune effector function, such as antibody production, cytotoxic activity, or cytokine production, characterization and function of dendritic cells and other antigen presenting cells, identification of biomarkers for specific immune responses, receptor repertoire analysis of responding T or B cells, and in vivo imaging techniques. This component should include support for personnel with relevant documented expertise and sufficient effort dedicated to sustain a vigorous resource development program. Funds for general supplies and specialized reagents should also be requested. Scale-up plans for the production and distribution of new reagents should be included. The applicant should explain the value of the resources proposed for development, both within the context of other resources currently available to Center investigators, and of resources available to the general immunology research community. A plan must be proposed for periodic evaluation of scientific progress. Based on such internal evaluations, as well as assessments made by the Centers Steering Committee (see below), replacement projects may be proposed at any time by the Principal Investigator for review and approval by the NIAID. Such replacement projects will not undergo additional peer review. When appropriate, new and/or improved assay, reagent, and technology protocols will be made publicly available. (2) Research Project Component (40%) This program will not support clinical trials, HIV research, and behavioral research. Basic or applied research projects must focus on immunology research in the context of the prevention or treatment of NIAID category A-C pathogen- mediated disease. A minimum of three research projects is required. Applicants are strongly encouraged to include both basic researchers and those with clinical experience as project leaders, and to establish close collaborations between the basic and clinical scientists. Animal studies are allowed, but only if they are clearly relevant to the human disease, and only if plans are described for translating the results into studies on human cells or tissues within the five-year funding period. Multidisciplinary approaches are encouraged. Each project should address a common scientific theme such that synergy is evident. A plan must be proposed for periodic evaluation of scientific progress. For projects that include animal studies, the potential to begin studies in humans must be evaluated periodically. Based on such internal evaluations, as well as assessments made by the Centers Steering Committee (see below), replacement projects may be proposed at any time by the Principal Investigator for review and approval by the NIAID. Such replacement projects will not undergo additional peer review. (3) Core Facility Component (10%) Facilities to support the Research Projects and/or to facilitate management of the Center and interactions among the Centers may be proposed if they will be utilized by at least two of the Research Projects, by the Research Resource Technical Development Component plus at least one of the Research Projects, or by the Principal Investigator for administration of the program. Such core facilities should be well justified and clearly non-duplicative of other facilities or services available to the Center investigators. If replacement projects significantly change the use of such facilities, funds may be rebudgeted within the Center after approval by the NIAID. Facilities may include administrative, clinical, statistical, technical (e.g., flow cytometry, proteomics), or other supportive activities. If appropriate to the particular Center, repositories for cells, tissues, or reagents may be funded under this component. In this case, proposals should include methods to obtain, protect, and archive relevant pathological, clinical, and family history information. In addition, appropriate informatics capability should be provided to track data and link to other data sets. A plan for distribution of samples should also be included and should conform to the NIH policy on data and resource sharing (http://www.nih.gov/science/models/sharing.html). (4) Pilot Project Component (5%) In order to take maximum advantage of new research opportunities, to provide support for high-risk, high-impact ideas, and to promote collaborations, applicants should include examples of two pilot projects to support feasibility studies likely to lead to independent R01 funding. The research proposed should focus on NIAID Category A-C agents. This component is intended to provide additional flexibility to the program and will support studies of limited duration (six months to two years) and of limited budget ($50-100,000 direct costs per pilot project per year). These funds may not be used for equipment purchase. Applicants should provide a short description of two proposed pilot projects as examples to be used during the review of the Center application. The description should be covered in three pages or less, and will serve to demonstrate the applicant"s capabilities to conceptualize and design novel studies. Award of the Cooperative Agreement does not imply that these particular proposed pilot projects will be implemented. In the application, the Principal Investigator should describe a process for the proposal, review, and selection of the actual pilot projects to be submitted for NIAID approval for implementation by that Center. Pilot projects that include collaborations between Centers will be encouraged in order to take advantage of specialized expertise and to promote further synergy. (5) Education Component (5%) The applicant should include plans to train laboratory staff, postdoctoral fellows, or faculty members in the use of assays, reagents, or technologies to study human immunology in the context of biodefense. Centers will be strongly encouraged to include trainees from non-Center laboratories in addition to Center laboratories. Education on the principles of human immunology may also be included, although formal courses will not be supported. Funds may not be used to support the salaries or stipends of the trainees. However, funds may be used for appropriate research supplies, and to compensate the effort of the facility personnel that provide the training. In addition, funds may be used to cover travel, housing, and per diem expenses, for a period up to two weeks, for non-government scientists from other domestic institutions to visit the Center to learn new techniques. Up to five visiting scientists may be supported per year in this manner. Finally, these funds may be used to support a seminar series or symposia comprised of speakers invited from other institutions to present research results on the immunology of NIAID Category A-C infectious diseases. A plan for the process to be used for selection of trainees should be included in the application. Research Projects and Pilot Projects must include research on NIAID Category A-C pathogens or their products. Such research may include, but is not limited to: molecular mechanisms of innate immunity, innate immune receptors as targets for adjuvant development, passive immunotherapy mediated by innate immune molecules, antibodies, or soluble receptors, mechanisms of synergy and regulation at the innate-adaptive immune interface, optimization of antimicrobial B and T cell effector mechanisms, antigen processing and presentation to T cells, antigen presenting cell functions, mechanisms of mucosal immunity, immunoregulation in the neonate or the elderly, generation and maintenance of B and T cell memory, mechanisms of microbial immune evasion, and in vivo imaging of immune responses. Inclusion of an external Scientific Advisory Committee may be proposed but is not required. If proposed, the applicant should explain the duties of such a Committee, and should include costs for meetings of Committee members with Center personnel. However, specific potential members of an external Scientific Advisory Committee should not be proposed in the application and should not be contacted prior to award. MECHANISMS OF SUPPORT This RFA will use the NIH Exploratory/Developmental Research Project Grant mechanism (R21) to fund activities to plan a U19 application, as well as the NIH Multi-Project Cooperative Agreement mechanism (U19). The total requested project period for an application submitted in response to this RFA may not exceed one year for an R21. The U19 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." Essential elements of the multi-project cooperative agreement mechanism also include: (1) a minimum of three interrelated individual research projects organized around a central theme, (2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal, (3) a single Principal Investigator who will be scientifically and administratively responsible for the group effort, and who must commit an appropriate level of effort to the program, (4) a single applicant institution that will be legally and financially responsible for the use and disposition of the funds awarded, and (5) support provided, as necessary, for "Core" resources or facilities, each of which is expected to be utilized by at least two research projects in order to facilitate the research effort. Construction or renovation costs are not allowed under this RFA. At some institutions, the nucleus of a research group that could conduct a U19 Centers program as described in this RFA may already exist, and such groups will be able to submit suitable applications for U19 awards directly. However, some groups may need an opportunity to establish themselves and formulate plans in preparation for submitting a U19 application. The Exploratory Grant (R21) mechanism may be used when the applicant wishes to request a one-year period of planning and preliminary investigation prior to preparing a U19 application. The R21 application may request one-year funds for partial salaries of key investigators and technical staff, as well as for supplies and small equipment needs. The direct costs requested are not to exceed $200,000. Although there is no minimum effort requirement for the Principal Investigator of a R21 grant, an appropriate commitment must be made. A R21 grant is not required as a precursor to a U19 Center application. Furthermore, funding of a R21 grant does not obligate the NIAID to fund a subsequent U19 Center grant. The NIAID expects to re-announce this RFA next year for U19 grants only, in order to accept revised or new U19 applications for funding in fiscal year 2004. However, re-announcement of the RFA will be dependent on the availability of sufficient funds. Therefore, this RFA may be a one-time solicitation. Furthermore, future unsolicited, competing-continuation applications based on this project will compete with all investigator- initiated applications and will be reviewed according to the customary peer review procedures. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The NIAID intends to commit approximately $12M in FY 2003 to fund approximately 3 U19 grants and 5-7 R21 grants in response to this RFA. An applicant may request a project period of up to five (5) years for the U19 and one year for an R21. Applicants may request up to $2,000,000 annual direct costs for U19 grants, and up to $200,000 annual direct costs for R21 grants. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each U19 award will also vary. Although the financial plans of the NIAID provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Investigators whose applications direct costs are over $2,000,000 must contact program staff (listed below) and receive a written letter of approval stating NIAID will accept and review the application. This is no way guarantees funding. 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 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 A. Requirements for U19 Application U19 applications in response to this RFA must be prepared using a multi- project grant application format, as described at http://www.niaid.nih.gov/ncn/grants/multibron.htm The U19 grant application should specify the administrative and organizational structure(s) that will be used to support the research. The synergies to be achieved through the establishment of multidisciplinary teams and novel collaborators should be fully described. The Principal Investigator is responsible for ensuring that the scientific goals are met, and for developing and managing a decision- making structure and process that will allow resources to be allocated, and re-allocated if necessary, to meet these goals. The application should explain how the different components of the Center, including key personnel, will interact, and why they promote synergy. "Centers-without-walls" are welcome under this RFA, if proposed, the applicant should address how such interactions will be facilitated. Milestones of Progress Applications must describe 6- and 12-month milestones for each Center, to include timelines for establishment and operation of each component, and scientific milestones for the Research Resource Technical Development and Research Projects components. NIAID encourages applicants to present explicit, quantitative milestones. It is recognized that milestones may require revision and re-negotiation during the course of the project period. Release of each funding increment by NIAID will be based on a NIAID review of progress towards achieving the previously agreed upon milestones. Pilot Projects Innovative Pilot Projects will be an integral part of this program. Applicants should provide a short description of two proposed Pilot Projects as examples to be used during the review of the Center application. The description should be covered in three pages or less, and will serve to demonstrate the applicant"s capabilities to conceptualize and design novel studies. Award of the Cooperative Agreement does not imply that the particular proposed Pilot Projects will be implemented. A plan for the proposal, review, and implementation of Pilot Projects by Center investigators must be included in the application. Projects recommended by the Principal Investigator must receive NIAID approval before implementation. Studies with Human Samples Although clinical trials will not be supported under this RFA, human samples will be utilized in the research supported by this program. The NIAID Scientific Coordinator (see below) will facilitate compliance with NIH policies for monitoring activities commensurate with the degree of potential risk to human subjects. The NIAID policy including terms and conditions of award is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. As examples, the NIAID Scientific Coordinator might assist Centers with responses to questions on human subject protection, might facilitate interactions with FDA personnel, and might assist in the preparation of INDs. Statement of Institutional Commitment The applicant institution should demonstrate its commitment to the stability and success of the Center by providing a statement of commitment that includes a plan addressing how the institutional commitment will be established and maintained, how the institution will maintain accountability for promoting scientific excellence, and how the Cooperative Centers for Translational Research on Human Immunology and Biodefense program will be given a high priority within the institution relative to other research efforts. Examples of institutional commitment include support for recruitment of scientific talent, provision of discretionary resources to the Principal Investigator, assignment of specialized research space, and cost sharing of resources or large equipment. A letter from the Dean confirming this commitment should be attached to the application. If a Center involves a consortium arrangement between two or more institutions, the parent institution that submits the application must receive a formal written agreement(s) from the other participant institutions that clearly delineates the institutional commitment of the participating organization(s). Intellectual Property Rights Institutions" rights in inventions made under this funding mechanism and the reporting requirements for such inventions will be governed by Public Law 96- 517 (the Bayh-Dole Act of 1980), 35 U.S.C. Secs. 200-212, 37 C.F.R. Part 401, and 45 C.F.R. parts 6 and 8. Institutions and investigators are expected to share background technology and intellectual property on a non-exclusive and royalty-free basis with other participating institutions as required to carry out the aims of the collaborative projects. In the event of a joint invention involving multiple institutions, the co-inventors" institutions are expected to cooperate in the filing of any resulting patent applications and in developing a plan to achieve commercial application of the technology. Applicants are expected to abide by the "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources," as published in the Federal Register December 23, 1999, Volume 64, Number 246, Pages 72090-72096. The Centers Steering Committee will be asked to develop a policy on publication and sharing of data obtained by the collaborative efforts of the Cooperative Centers for Translational Research on Human Immunology and Biodefense. Annual Workshop Principal Investigators will be expected to participate in an annual workshop organized by the Centers Steering Committee in order to: share both positive and negative results with other Centers, share materials including reagents and techniques, assess progress, identify new research opportunities, and establish research priorities and collaborations that will maximize the impact of the program to improve human vaccines and immunotherapies for biodefense. Therefore, travel funds for the Principal Investigator and other selected Center investigators and collaborators should be budgeted for this purpose. A Centers Steering Committee meeting will also be held in conjunction with the workshop. B. Organizational Requirements for U19 Awards Centers Steering Committee Within 2 months of award, the NIAID will establish a Centers Steering Committee to serve as the governing body of the Cooperative Centers for Translational Research on Human Immunology and Biodefense. At a minimum, the Steering Committee will be composed of the Principal Investigators of each of the awarded U19 grants and the NIAID Scientific Coordinator. Each member of the Steering Committee will have one vote. The Steering Committee or the NIAID may identify and appoint other members, as appropriate. A Chairperson will be selected by the Steering Committee from among the non-federal Committee members. Subcommittees of the Steering Committee may be established as necessary. The Steering Committee will meet 3 times during the first year, including a meeting in conjunction with the Annual Workshop, and semi-annually thereafter. Proposed budgets should include funds to cover travel costs for these meetings. Each Steering Committee member will be expected to participate in all meetings and activities, e.g., conference calls and special subcommittees, as may be necessary for optimal operation of the CooperativeCenters for Translational Research on Human Immunology and Biodefense program. The Steering Committee will be responsible for: promoting synergistic interactions within each Center and among the Centers, evaluating the use of Education Components, evaluating plans for the redirection of ongoing projects for NIAID approval, developing a policy on publication and sharing of data obtained by the collaborative efforts of the Centers, and recommending the incorporation of additional expertise or research resources. Separate funds will be available to the Steering Committee to support the Cooperative Resources deemed necessary. Cooperative Resources The Centers Steering Committee may establish and support Cooperative Resources that provide central assistance and technical expertise for projects undertaken by Center investigators under this program. Examples include genomic/proteomic, tetramer, or sophisticated flow cytometry facilities. The Centers Steering Committee will determine procedures for the designation of such Cooperative Resources, and will determine the scope of work and level of support based on Center priorities and requirements. Non-administrative Core Facilities proposed by individual Centers may be expanded to become Cooperative Resources using the separate funds available to the Centers Steering Committee. Cooperative Resources may be housed at particular Centers or may be supported through a subcontract to other facilities. Cooperation with Other NIH-Sponsored Programs In order to most efficiently utilize research resources and rapidly exchange scientific information to promote biodefense objectives, the Cooperative Centers for Translational Research on Human Immunology and Biodefense will coordinate their efforts with other NIH-funded programs, including but not limited to the following NIAID programs: Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research, Vaccine and Treatment Evaluation Units, Biodefense and Emerging Infections Research Resource Program, Tetramer Facility, Respiratory Pathogens Network, Food and Waterborne Diseases Integrated Research Network, Immune Tolerance Network, and International Histocompatibility Working Group. GUIDANCE FOR R21 PLANNING GRANT APPLICATIONS Applicants should follow a single-project application format describing the activities proposed for a one-year period that will prepare the Principal Investigator to submit a U19 application in response to a future RFA to support Cooperative Centers of Translational Research on Human Immunology and Biodefense (CCTRHIB). Appropriate activities may include, but are not limited to: the establishment or expansion of multi-investigator or interdisciplinary relationships, exploration of organizational concepts, building an administrative organization, development of the rationale and research design for the subsequent Center, development of assays or technologies for the Research Resource Technical Development component, and the collection of preliminary data for the Research Projects component. These activities should be described in the context of the anticipated U19 Center grant application goals and requirements. Funds may be used for salary support, as appropriate, training in scientific procedures, travel to establish collaborations, or laboratory supplies and small equipment. The standard PHS 398 form should be used and sections A-D must not exceed 25 pages. A modular budget should be proposed (https://grants.nih.gov/grants/funding/modular/modular.htm). In order to indicate that the application is for an R21 award, please use the following Application Title: "R21 Planning Grant for the CCTRHIB Program". Also, please state in the Abstract that the application is for an R21 Planning Grant for the CCTRHIB Program. In the Research Design and Methods section of the application, please describe your plans for assembling appropriate Center member candidates, and plans to obtain any needed preliminary data or research resources, to support a future U19 application. Plans to develop each of the essential components of a U19 application should be included: the Research Resource Technical Development, Research Projects, Core Facilities, Pilot Projects, and Education components. For each component, describe the particular strengths to be incorporated into a potential Center and the advantages of such a Center to the CCTRHIB program as a whole. Describe available infrastructure and how you will build on these resources. Provide sufficient information to allow reviewers to realistically evaluate the probability that a strong U19 application can be developed within the one-year time frame. COOPERATIVE AGREEMENT (U19) TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the multi- project cooperative agreement (U19). The U19 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described below. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the research will be shared among the awardees and the NIAID Scientific Coordinator. 1. Monitoring Human Subjects Protection. When human samples are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to human subjects. Terms and Conditions of Award will be included with awards. The NIAID policy including terms and conditions of award is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. 2. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the research objectives, approaches and details of the projects within the guidelines of the RFA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below. Milestones of Progress Each Center must establish 6- and 12-month milestones and timelines for establishment and operation of each component, and scientific milestones for the Research Resource Technical Development and Research Projects components. NIAID encourages applicants to present explicit, quantitative milestones. It is recognized that milestones may require revision and re-negotiation during the course of the project period. Release of each funding increment by NIAID will be based on a NIAID review of progress towards achieving the previously agreed upon milestones. Pilot Projects Award of the Cooperative Agreement does not imply that the particular proposed Pilot Projects will be implemented. A plan for the proposal, review, and implementation of Pilot Projects by Center investigators must be included in the application. Projects recommended by the Principal Investigator must receive NIAID approval before implementation. The research proposed must focus on NIAID Category A-C agents. This component is intended to provide additional flexibility to the program and will support studies of limited duration (six months to two years) and of limited budget ($50-100,000 direct costs per pilot project per year). These funds may not be used for equipment purchase or renovations. Studies with Human Samples Although clinical trials will not be supported under this RFA, human samples will be utilized in the research supported by this program. The NIAID Scientific Coordinator (see below) will facilitate compliance with NIH policies for monitoring activities commensurate with the degree of potential risk to human subjects. The NIAID policy including terms and conditions of award is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. As examples, the NIAID Scientific Coordinator might assist Centers with responses to questions on human subject protection, might facilitate interactions with FDA personnel, and might assist in the preparation of INDs. The NIH brochure entitled "Research on Human Specimens: Are You Conducting Research Using Human Subjects?" may also be of use to applicants (http://www-cdp.ims.nci.nih.gov/policy.html). Intellectual Property Rights Institutions" rights in inventions made under this funding mechanism and the reporting requirements for such inventions will be governed by Public Law 96- 517 (the Bayh-Dole Act of 1980), 35 U.S.C. Secs. 200-212, 37 C.F.R. Part 401, and 45 C.F.R. parts 6 and 8. Institutions and investigators are expected to share background technology and intellectual property on a non-exclusive and royalty-free basis with other participating institutions as required to carry out the aims of the collaborative projects. In the event of a joint invention involving multiple institutions, the co-inventors" institutions are expected to cooperate in the filing of any resulting patent applications and in developing a plan to achieve commercial application of the technology. Applicants are expected to abide by the "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources," as published in the Federal Register December 23, 1999, Volume 64, Number 246, Pages 72090-72096. The Centers Steering Committee will be asked to develop a policy on publication and sharing of data obtained by the collaborative efforts of the Cooperative Centers for Translational Research on Human Immunology and Biodefense. Annual Workshop Principal Investigators must participate in an annual workshop organized by the Centers Steering Committee in order to: share both positive and negative results with other Centers, share materials including reagents and techniques, assess progress, identify new research opportunities, and establish research priorities and collaborations that will maximize the impact of the program to improve human vaccines and immunotherapies for biodefense. A Centers Steering Committee meeting will also be held in conjunction with the workshop. Centers Steering Committee Within 2 months of award, the NIAID will establish a Centers Steering Committee to serve as the governing body of the Cooperative Centers for Translational Research on Human Immunology and Biodefense. At a minimum, the Steering Committee will be composed of the Principal Investigators of each of the awarded U19 grants and the NIAID Scientific Coordinator. Each member of the Steering Committee will have one vote. The Steering Committee or the NIAID may identify and appoint other members, as appropriate. A Chairperson will be selected by the Steering Committee from among the non-federal Committee members. Subcommittees of the Steering Committee may be established as necessary. The Steering Committee will meet 3 times during the first year, including a meeting in conjunction with the Annual Workshop, and semi-annually thereafter. Each Steering Committee member must participate in all meetings and activities, e.g., conference calls and special subcommittees, as may be necessary for optimal operation of the Cooperative Centers for Translational Research on Human Immunology and Biodefense program. The Steering Committee will be responsible for: promoting synergistic interactions within each Center and among the Centers, evaluating the use of Education Components, evaluating plans for the redirection of ongoing projects for NIAID approval, developing a policy on publication and sharing of data obtained by the collaborative efforts of the Centers, and recommending the incorporation of additional expertise or research resources. Separate funds will be available to the Steering Committee to support the Cooperative Resources deemed necessary. Cooperative Resources The Centers Steering Committee may establish and support Cooperative Resources that provide central assistance and technical expertise for projects undertaken by Center investigators under this program. Examples include genomic/proteomic, tetramer, or sophisticated flow cytometry facilities. The Centers Steering Committee will determine procedures for the designation of such Cooperative Resources, and will determine the scope of work and level of support based on Center priorities and requirements. Non-administrative Core Facilities proposed by individual Centers may be expanded to become Cooperative Resources using the separate funds available to the Centers Steering Committee. Cooperative Resources may be housed at particular Centers or may be supported through a subcontract to other facilities. Cooperation with Other NIH-Sponsored Programs In order to most efficiently utilize research resources and rapidly exchange scientific information to promote biodefense objectives, the Cooperative Centers for Translational Research on Human Immunology and Biodefense will coordinate their efforts with other NIH-funded programs, including but not limited to the following NIAID programs: Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research, Vaccine and Treatment Evaluation Units, Biodefense and Emerging Infections Research Resource Program, Tetramer Facility, Respiratory Pathogens Network, Food and Waterborne Diseases Integrated Research Network, Immune Tolerance Network, and International Histocompatibility Working Group. 3. NIAID Staff Responsibilities A program officer from the Basic Immunology Branch, Division of Allergy, Immunology, and Transplantation, NIAID, will serve as NIAID"s Scientific Coordinator and will provide NIAID staff assistance. The NIAID Scientific Coordinator will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. The NIAID Scientific Coordinator will attend all Centers Steering Committee meetings and participate with one vote in this and in other Committee and Subcommittee activities. The NIAID Scientific Coordinator will also provide expertise in technology and resource development, availability, and application, development, design, and implementation of studies with human samples, policies and procedures for the protection of human subjects, and will serve as a liaison to other NIH-sponsored programs to facilitate collaboration and coordination. In addition, the NIAID Program Director, a program officer from the Basic Immunology Branch, Division of Allergy, Immunology and Transplantation, NIAID, will be responsible for normal programmatic monitoring and stewardship for the award. The NIAID Program Director will approve changes in proposed milestones, approve proposed Pilot Projects, and approve redirection of Research Projects or Research Resource Technical Development components. The NIAID Program Director will review progress through consideration of annual progress reports and periodic reports on ongoing progress, findings, and future plans presented during meetings and conference calls, publications, site visits, etc. The NIAID Grants Management Specialist, in consultation with the NIAID Program Director, must approve in writing any changes in the Principal Investigator of the U19 grant, or changes in the Principal Investigator of a Research Resource Technical Development or Research Project component. The NIAID Program Director may also serve as the NIAID Scientific Coordinator. 4. Collaborative Responsibilities Collaborative responsibilities are as detailed above in the section on Cooperative Agreement (U19) Terms and Conditions of Award under "Awardee Rights and Responsibilities" for the Centers Steering Committee, Milestones of Progress, Pilot Projects, Cooperative Resources, and Intellectual Property sections. 5. Arbitration Any disagreement that may arise on scientific or programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Steering Committee or by the individual awardee in the event of an individual disagreement, a second member selected by the NIAID, and the third member with expertise in the relevant area and selected by the two prior members will be formed to review any scientific or programmatic issue that is significantly restricting progress. While the decisions of the Arbitration Panel are binding, these special arbitration procedures will in no way affect the awardee"s right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, subpart D, and HHS regulations at 45 CFR Part 16. WHERE TO SEND INQUIRIES We strongly encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Helen Quill, Ph.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases Room 5140, MSC-7640 6700-B Rockledge Drive Bethesda, MD 20892-7640 Telephone: (301) 496-7551 FAX: (301) 402-2571 E-Mail: hq1t@nih.gov o Direct your questions about peer review issues, address the letter of intent, mail two copies of the application and all five sets of appendices to: Ed Schroder, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2151, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) 435-8537 FAX: (301) 402-2638 E-Mail: es170m@nih.gov o Direct your questions about financial or grants management matters to: Ann Devine Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2118, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 402-5601 Fax: (301) 480-3780 E-Mail: ad22x@nih.gov LETTER OF INTENT Prospective applicants for U19 or R21 grants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows 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: Ed Schroder, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2151, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 (20817 for express mail) Telephone: (301) 435-8537 FAX: (301) 402-2638 E-Mail: es170m@nih.gov SUBMITTING AN APPLICATION Applicants for U19 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS, this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. Applications for U19 and R21 grants must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://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. USING THE RFA LABEL: For both U19 and R21 applications, the RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 exact copies of the grant application and all five sets of any appendix material must be sent to: Ed Schroder, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2151, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 (20817 for express mail) Telephone: (301) 435-8537 FAX: (301) 402-2638 E-Mail: es170m@nih.gov Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 5/01) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged non-responsive and will be returned to the applicant. It is highly recommended that the appropriate NIAID program contact be consulted before submitting the letter of intent and during the early stages of preparation of the application. (See scientific/research program contact under INQUIRIES). APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. Concurrent submission of an R01 and a Component Project of a Multi-project Application: Current NIH policy permits a component research project of a multi-project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAID. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. 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 the National Institute of Allergy and Infectious Diseases Council REVIEW CRITERIA The GENERAL REVIEW CRITERIA for U19 multi-project cooperative agreement applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" at http://www.niaid.nih.gov/ncn/grants/multibron.htm. SPECIFIC REVIEW CRITERIA for U19 applications: In addition to the above criteria, your application will also be reviewed with respect to the following: 1. Organization and Scientific Potential of the Center (a) Adequacy of the applicant"s plan to establish, coordinate, and manage a synergistic research program to achieve the goals of the Cooperative Centers for Translational Research on Human Immunology and Biodefense program. (b) Sufficient focus on human immunology and assay, reagent and technology development. (c) Scientific/technical merit and innovation of the proposed goals of the Center. (d) Expertise and productivity of proposed Center investigators. (e) Potential of the proposed Center to develop critical new knowledge about the immunology of Category A-C biodefense and emerging infectious diseases. (f) Merit and appropriateness of the documented institutional support to the goals of the Center. (g) Adequacy and feasibility of applicant"s described milestones of progress that will be used to assess productivity and accountability. 2. Research Resource Technical Development Component Adequacy of the applicant"s plans to develop, validate, and disseminate new assays, reagents, and technologies for the timely and optimal study of human immunology for biodefense. 3. Research Project Component (a) Adequacy of the applicant"s plans to conduct synergistic basic and/or applied research on Category A-C pathogens to discover fundamentally new principles of human immunity and/or to promote the most rapid progress in achieving applications for human protection. (b) Technical feasibility of plans to conduct studies with human samples or to translate results from animal work into the human. 4. Core Facilities Component (a) Appropriateness of the proposed core facilities in the context of the overall research plan of the Center application and the context of currently available facilities. (b) Feasibility and clarity of plans for prioritizing the use of facilities by Center members. (c) Use of core facilities to conserve resources for common tasks such as MHC typing, microarray gene or protein expression assays, or MHC-peptide tetramer generation. 5. Pilot Project Component (a) Scientific strengths of the two proposed examples of pilot projects in the context of Category A-C agents. (b) Adequacy, fairness, and scientific basis of the applicant"s plans to propose pilot projects for implementation. (c) Plans to monitor success of the pilot projects in terms of subsequent independent funding obtained to further develop the projects begun as pilots. 6. Education Component (a) Adequacy of the applicant"s plans to select and train laboratory staff, postdoctoral fellows, faculty members, and scientists who are not Center members in the use of assays, reagents, and technologies to study human immunology in the context of biodefense. (b) Appropriateness of plans to support short-term training for scientists from non-Center institutions, if proposed. (c) Appropriateness of plans to support seminar series/symposia, if proposed. SPECIAL REVIEW CRITERIA for R21 applications: your application will be reviewed to determine the probability that a strong U19 application can be developed, within the one-year period of award, that satisfies the criteria listed above for a U19 grant. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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 included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 20, 2002 Application Receipt Date: January 22, 2003 Scientific Peer Review Date: June 2003 Advisory Council Review: July 2003 Earliest Anticipated Start Date: September 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS 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: https://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 AMENDMENT "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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at https://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 https://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 https://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 https://grants.nih.gov/grants/stem_cells.htm and at https://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 https://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. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH Grants Policy Statement is available at https://grants.nih.gov/grants/policy/policy.htm. This document includes general information about the grant application and review process, information on the terms and conditions that apply to NIH Grants and cooperative agreements, and a listing of pertinent offices and officials at the NIH. 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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