CDC PUBLIC HEALTH RESEARCH: HEALTH PROTECTION RESEARCH INITIATIVE CENTERS OF EXCELLENCE IN HEALTH PROMOTION ECONOMICS CENTER CORE GRANT (P30) RELEASE DATE: April 22, 2004 RFA Number: RFA-CD-04-004 EXPIRATION DATE: June 22, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: Office of the Director (OD), Office of Science Policy and Technology Transfer (OSPTT), Office of Public Health Research (OPHR) (http://www.cdc.gov/od/ads/) Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by NIH. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.061 LETTER OF INTENT RECEIPT DATE: May 24, 2004 APPLICATION RECEIPT DATE: June 21, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Center Director o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplemental Instructions o Peer Review Process o Review Criteria o Additional Considerations o Receipt Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Centers for Disease Control and Prevention (CDC), Office of Science Policy and Technology Transfer (OSPTT), Office of Public Health Research (OPHR) announces the availability of FY 2004 funds to provide core support for the establishment of Centers of Excellence in Health Promotion Economics. This RFA is a component of the CDC’s FY 2004 Health Protection Research initiative. Health protection should be interpreted to include activities that 1) promote health and or prevent disease, injury, or disability or 2) protect people from health threats including infectious, environmental, and terrorist threats. Centers of Excellence in Health Promotion Economics will apply economic theory and methods to areas that have a high probability of improving the efficiency and effectiveness of priority health protection activities. Health promotion economics is defined as the study of the relationship between society’s resources and its efforts to promote health. The demand for health promotion-related goods and services exceeds the available resources, so means must be devised to allocate these resources between competing ends. Research in health promotion economics should be interpreted to include, but not be limited to, that which 1) explores economic priorities, barriers and solutions to developing, implementing, and evaluating health promotion policies, guidelines, recommendations, and programs; 2) examines supply and demand for health promotion including examination of market imperfections and externalities; and 3) evaluates the cost effectiveness and efficiency of such polices and programs. Health promotion focuses on creating policies and developing behaviors that result in lowering the risk of disease, injury and disability. By promoting health (through physical activity, diet, etc.) and preventing disease, injury, and disability (through the use of seat belts, antimicrobial prophylaxis therapy, etc.), people are given the opportunity to achieve their expected lifespan with the best possible quality of health in every life stage. RESEARCH OBJECTIVES Background The large discrepancies between what Americans spend on health and the outcomes they experience may stem from how the nation’s health knowledge and resources are deployed within the health system and other sectors of society. Most health resources are deployed when people seek care for specific diseases and health conditions. Currently, health protection, health promotion, and prevention activities account for about 3% of the nation’s investment for health services. CDC has aligned its priorities and investments with those of the Department of Health and Human Services to achieve 2 overarching health protection goals: 1) Health promotion/Disease, injury and disability prevention: All people will achieve their optimal lifespan with the best possible quality of health in every life stage. The strategy to accomplish this goal includes developing the knowledge and tools that integrate perspectives from multiple scientific disciplines to focus on health evolving in life stages over a lifetime (infants, children, adolescents, young adults, middle-age adults, and older adults), and in all situations (at work, in communities, in school, at home, and at play). Integral to the successful accomplishment of this goal is the elimination of health disparities that afflict many people in our society. 2) Preparedness: People in all communities will be protected from infectious, environmental, and terrorist threats. The strategies to accomplish this goal include developing the knowledge and tools that integrate perspectives from multiple scientific disciplines to focus on exposure prevention, rapid detection and diagnosis, investigation, containment, and recovery from health threats. CDC’s health protection research initiative is designed to support achievement of these goals, and will help develop and disseminate the knowledge and tools that can be used by individuals, public health professionals, health care providers, educators, policy makers, businesses, private sector organizations, and others to measurably improve the health of Americans and reduce health disparities at all life stages and in all settings. This RFA focuses specifically on health promotion. A major obstacle to giving greater priority to health promotion is the fact that there is insufficient evidence on economic factors that influence specific programs, practices, and policies that affect health decisions made by people and those responsible for health policies and programs in the public health, healthcare delivery, and educational systems, as well as their counterparts in businesses and other private sector enterprise, governments, and governmental agencies. CDC has initiated the establishment of Centers of Excellence in Health Promotion Economics as one key component of its public health research agenda to address this knowledge gap in health promotion. A proactive approach to health promotion may be economically beneficial. With more than 60% of U.S. adults being overweight or obese, annual U.S. obesity- attributable medical expenditures are estimated at $75 billion in 2003 dollars. Research Objectives The primary objective of this funding is to establish Centers of Excellence in Health Promotion Economics that would explore economic solutions to developing, evaluating, and implementing health promotion guidelines, recommendations, programs, and policies; and to evaluate their cost-effectiveness, consequently improving upon all aspects of health promotion-related efforts. A Center of Excellence in Health Promotion Economics would represent an organization or academic setting with a critical mass of researchers and teachers to bring the discipline of health economics to the examination, design, implementation, and evaluation of health promotion policies and programs. An optimal setting for a Center of Excellence would include the following: o Trans-disciplinary setting with expertise in fields such as public health, economics, epidemiology, demography, biostatistics, and behavioral sciences. o Access to and established relationships with a variety of entities involved in health promotion research and its evaluation, translation and implementation, such as the state health department, school of public health, other government entities such as the cooperative extension service, businesses, and community organizations. o Institutional capacity in research and teaching. Core faculty in several of the following priority areas: econometrics, decision science, health policy, economic evaluation, macroeconomics, management, health care finance, industrial engineering, operational research, and environmental health economics. Strategies Priority will be given to strategies that employ health promotion economics to address major actual causes of death in the United States (JAMA. 2004; 291(10):1238-1245), e.g., obesity, diabetes, poor nutrition, and lack of adequate physical activity: O Conducting research in health promotion economics includes: o Estimating economic burden of disease, determinants of health and health disparities o Identifying and examining the role of economic incentives and barriers to health promotion and the adoption of healthy lifestyles o Investigating supply and demand for health promotion activities including market imperfections and externalities o Evaluating the costs and cost-effectiveness of health promotion policies and programs o Examining the role of health care financing on the delivery of health promotion programs and interventions o Identifying structural solutions to improving health promotion programs within the existing primary health care structure and through linkages between the clinic and the community o Examining return on investment in public health and health promotion at the macroeconomic level. O Providing training in health promotion economics to one or more of the following: o MPH and PhD students o Medical students, o Post-docs (residents and fellows) o State and local health departments o Community-based organizations o Members of the health care delivery system. O Linking with health promotion implementers to evaluate the cost effectiveness of their activities and to incorporate findings from economic research into programs and policies, thereby improving their effectiveness and efficiency. MECHANISM OF SUPPORT This RFA will use the Research Center Core (P30) grant award mechanism. The purpose of this mechanism is to support shared resources and facilities for a specific area of scientific inquiry by a number of investigators who provide an interdisciplinary and multidisciplinary approach to a joint research effort or who focus on a common research problem. The Center is funded independently from the currently funded projects but is integrated with them to provide support. Responsibility for the planning, direction, execution and evaluation of the proposed Center will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed three years. This RFA is a one-time solicitation. The earliest anticipated award date is September 30, 2004. This RFA uses just-in-time concepts. For details refer to the Applicants and Grantee Check lists accessible at URL: http://www.niaid.nih.gov/ncn/grants/charts/checklists.htm#gjit FUNDS AVAILABLE CDC intends to commit approximately $1,000,000 in FY 2004 to fund 1 new grant in response to this RFA. An applicant may request up to three consecutive 12-month budget periods within a project period of up to 3 years. Although the financial plans of CDC 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. At this time, it is not known if this RFA will be reissued. Matching funds are not required for this program. ELIGIBLE INSTITUTIONS Eligible institutions include: o Public or private academic institution o Eligible governmental public health agency o Unit of state, county, local, or tribal government o Healthcare organization o Research institution Foreign institutions are not eligible for the Center program grants. Institutions eligible for the Core Center grant are those at which there are at least three (3) research projects funded by Department of Health and Human Services (DHHS) grants from selected mechanisms (specifically, R01, R15, R18, R21, P01, P50, or U01) or comparable peer reviewed research projects, including those funded by state governments or private foundations. These research projects should be directly related to the scientific area of the proposed Center. Each of these projects in the research base must have at least one (1) year of committed support remaining at the time of the Center award, i.e., funding must continue through September 2005 at a minimum. A project that is in a no-cost extension phase does meet this requirement. A large number of DHHS awards in the scientific area of inquiry would strengthen an application. An applicant organization may submit only one (1) P30 application. Note: Title 2 of the United States Code section 1611 states that an organization described in section 501 (4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan. INDIVIDUALS ELIGIBLE TO BECOME CENTER DIRECTOR The Center Director must have a research, a health-professional doctorate, or its equivalent. Center Directors must be established in their field with expertise appropriate to the purpose of this RFA. Examples of appropriate career appointments could include faculty positions at academic institutions or similar research positions at other eligible institutions. The Center Director should have specific authority and responsibility to carry out the proposed project. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs. SPECIAL REQUIREMENTS The Center must be an identifiable organizational unit within a department, school, or college (such as public health, demography, biostatistics, economics, business, public finance, behavioral sciences, etc.). A Health Promotion Economics Core Center grant benefits from an interdisciplinary approach. When multiple organizations within an institution are represented in the application, clear lines of authority and sanction by the appropriate institutional officials must be specified. Each applicant institution must name a Center Director who will be the key figure in the administration, management, and evaluation of the Center grant. The Director will be responsible for the organization and operation of the Center. The Director should be experienced in conducting research and have demonstrated ability to coordinate, integrate, and provide guidance in the establishment of new programs in the scientific area of inquiry. The Director must commit a minimum of 75% of his or her full professional attention to these tasks. Funding is intended to support shared resources and facilities (core units) that will enhance and extend the effectiveness of research at the applicant institution. CORES A core is a shared central facility, such as an institute, service, or other resource. The core is directed by an investigator with substantial expertise related to the core. A core facility may be proposed that will enhance productivity or in other ways benefit a group of investigators to accomplish their stated goals. An important consideration is the degree to which the core facility will be utilized by and benefit individual ongoing-funded projects and Center investigators and will assist in the development of the scientific area of inquiry. The Center must have a minimum of three cores. (Administrative Core and Economics Core must be two of the three.) In a Core Center grant application, it is not sufficient for the applicant merely to identify such centralized resources. Rather, it must be demonstrated exactly how each core would augment or enhance the present capabilities of the investigators and make new activities possible. Administrative Core (Mandatory) An Administrative Core is mandatory for a Core Center. The Administrative Core should manage the overall activities of the Center. This should include the following: 1. A specified Director and Associate Director; 2. A description of the administrative structure; 3. A general description of overall facility and institutional commitment. It is expected that the Core Center administrative structure will accomplish the following: 1. Coordinate and integrate the Core Center grant components and activities; 2. Review the utilization of funds, including funds for pilot and feasibility studies; and 3. Provide information to the Core Center Director about the activities of the Center's cores. While the final administrative structure of the Core Center will, for the most part, be left to the discretion of the applicant institution, the effective development of Center programs requires interaction among the Director, the core leaders, the Principal Investigators of research projects using the cores, appropriate institutional administrative personnel and the staff of the awarding agency. An Executive Committee, consisting of the Associate Director and the PIs of the cores and the Business Official, should be established to assist the Director in making the scientific and administrative decisions relating to the Center. In addition to coordination of the Core Center, the Director, with his or her Executive Committee, will be responsible for allocation of Core Center funds, the identification and selection of key personnel, and the planning and evaluation of Core Center activities. The complex nature of administrative requirements of the Core Centers will necessitate the assistance of a person with business management expertise. It is important that such an official be identified and directly involved with the fiscal aspects of the Core Center application and grant. An appropriate amount of this individual's time and effort must be committed for this purpose. The institutional Business Official should be a member of the Executive Committee. While budget formulation and planning will undoubtedly begin with the Director in collaboration with the scientific staff, the Business Official must be involved in the process and provide oversight in matters of fiscal administration throughout the project period. The Business Official should attend the annual Director's meeting; funds should be requested in the budget for this purpose. Annual and close out reports will be required to include evaluation measures as specified in the evaluation plan. An Advisory Committee should be established and composed of scientists from within the institution and at least two (2) scientists from outside the applicant institution. This committee may also be used in evaluating the overall research programs of the Core Center, the effectiveness of communications within the Core Center, and any other activities in which problems arise for which expertise is required or desirable. If health disparities or emphasis on culture and ethnicity is chosen as a core, it is highly suggested that community representation be a part of the Advisory Committee. The Advisory Committee should meet at least once annually. However, the nature of its responsibilities may require ad hoc meetings at more frequent intervals. A member of the OPHR extramural program staff may attend meetings as an observer. The outcome of the Advisory Committee review must be part of the Core Center's annual report to the OPHR. For the purpose of this RFA, establishment of an Economics Core will be mandatory. o Economics Core (Mandatory) The Economics Core should be designed to furnish a group of investigators with focus to allow them to share data in a manner that will enhance the research progress. The requested resources and facilities must facilitate the collaboration and integration of the component projects, and support a synthesis of information that would not take place if each component core project were given its own independent resource facility by itself. Its aim is to stimulate multidisciplinary approaches to joint research efforts. It should be an economics intellectual hub around which cooperative and interactive research will be supported and stimulated. The use of shared resources can increase the efficiency of research by eliminating unnecessary duplication, promoting the development of new research directions, and promoting research interactions and collaborations. Other Core Units (One Mandatory) The applicant must propose at least one additional core that will promote scientific accomplishments that are congruent with the research base and the overall themes of the Center. Support is not allowed for cores that only replace or centralize resources supported on individual project grants. All cores must be well justified, conceptually linked to the scientific area of inquiry, and clearly demonstrate how the shared resources will enable investigators to conduct their independently funded research projects more efficiently and/or more effectively. Various types of other core units are acceptable. Examples of possible cores that may be proposed include: o Dissemination and Translation Core Supports dissemination and translation of economic solutions to developing, evaluating and implementing health promotion guidelines, recommendations, programs, and policies that influence health decisions made by people, schools, businesses, and health care delivery systems. Facilitates new skills and techniques as well as enhancing the exchange and dissemination of information critical to the scientific area of inquiry both within the Core Center and within the broader scientific community. o Analytic Support Core Provides centralized research equipment and services as well as data management functions such as data systems functions, data analysis and evaluation, economic and demographic data gathering, and biometry or statistical data coordination. Assistance from econometricians, computer experts, biostatisticians, epidemiologists, behavioral scientists, and other individuals who can assist or collaborate with the participating investigators in conducting surveys and research relevant to health promotion research practices and outcomes issues is desirable. o Health Disparities Core Provides the expertise to facilitate research focusing on health disparities, defined as behavioral studies on health conditions, health promotion attitudes, and economics including diseases, disorders, and such other conditions that are unique to, more serious, or more prevalent in sub-populations that are economically disadvantaged and medically underserved. Special populations also include racial and ethnic minority groups, generally defined as African Americans, Hispanics, Native Americans, Alaska Natives, Hawaiian Islanders, and Asian Pacific Islanders. Health disparities activities may stimulate research as well as facilitate the development of current and future minority investigators. If an emphasis on health disparities is chosen, it is recommended that community representation be a part of the Advisory Committee. Evaluation Plan A plan for evaluating progress toward aims and/or goals of each core and the overall Core Center is required. The evaluation must articulate how progress has advanced the discipline of health economics to the examination, design, implementation, and evaluation of health promotion policies and programs. This plan should include the specific criteria and methods that will be used for the evaluation. The plan should specify the types of evaluation information that will be submitted in the Center's annual progress reports. At a minimum, the evaluation plan is to include numbers of publications by Core Center staff. WHERE TO SEND INQUIRIES CDC encourages inquiries concerning this RFA and welcomes 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: Tanja Popovic, M.D., Ph.D., F.A.A.M. Acting Associate Director of Science Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road. N.E., Mailstop D-50 Atlanta, GA 30333 Telephone: (404) 639-7240 FAX: (404) 639-7341 Email: TPopovic@cdc.gov o Direct your questions about peer review issues to: Catherine Spruill Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road. N.E., Mailstop D-50 Atlanta, GA 30333 Telephone: (404) 639-7240 FAX: (404) 639-7341 Email: Cspruill@cdc.gov o Direct your questions about financial or grants management matters to: Sylvia Dawson Procurements and Grants Office Centers for Disease Control and Prevention Koger Office Park, Colgate Building, Mailstop E-14 2920 Brandywine Road Atlanta, GA 30341-5539 Telephone: (770) 488-2771 Email: Sdawson@cdc.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 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 CDC 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: Heidi Steele Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road. N.E., Mailstop D-50 Atlanta, GA 30333 Telephone: (770) 488-8612 FAX: (770) 488-8615 Email: HSteele@cdc.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 document is available in an interactive format at http://grants.nih.gov/grants/funding/phs398/phs398.html. The instructions for the Form PHS 398 do not entirely apply to the submission of these P30 grant applications. Accordingly, applicants are strongly encouraged to follow the SUPPLEMENTAL INSTRUCTIONS below, which have been adapted to accommodate the PHS 398 and the special requirements of this RFA. These instructions include all of the information that will be needed by the peer reviewers of these applications. SUPPLEMENTARY INSTRUCTIONS 1. Face Page: Use Form Page 1 as instructed in the PHS 398. On line 2, enter the number and title of this RFA. Remember to affix the RFA label that comes with the PHS 398 to the bottom of the Face Page. 2. Description, Performance Site(s) and Key Personnel: Use Form Page 2 of the PHS 398 and follow the instructions provided in the PHS 398. 3. Table of Contents: Provide a detailed Table of Contents organized as described below. This differs from Form Page 3 of the PHS 398. Content Page Number o Face Page o Description, Performance Sites and Key Personnel o Table of Contents, including List of all Tables and Figures o Detailed Budget for Initial Budget Period (Cores and Pilot/Feasibility Studies) o Budget for Entire Proposed Project Period (Cores and Pilot/Feasibility Studies) o Budgets Pertaining to Consortium/Contractual Arrangements (if applicable) o Budget Justification Pertaining to Consortium/ Contractual Arrangements (if applicable) o Biographical Sketch of the Principal Investigator (Center Director) o Biographical Sketches of All Professional Personnel and Pilot Investigators o List of participating faculty/members of the Center o Resources o Overview of Center and Description of Research Base o Economics Core, Budget, and Budget Justification o Mandatory Core #3, Budget, and Budget Justification o Optional Core(s), Budget, and Budget Justification o References o Letters of Support o Consortium/Contractual Arrangements o Checklist o Appendix Material 4. Detailed Budget for Initial Budget Period: Use Form Page 4 of the PHS 398 application kit. This budget should include total direct costs of the Cores. 5. Budget for Entire Proposed Project Period: Use Form Page 5 of the PHS 398 application kit. This budget should include total direct costs of the Cores for all years requested. 6. Budgets Pertaining to Consortium/Contractual Arrangements: Use Form Pages 4 and 5. These budgets are included if consortium/contractual arrangements are needed. 7. Budget Justification Pertaining to Consortium/Contractual Arrangements: if applicable. 8. Biographical Sketch of Principal Investigator (Center Director): Use the Biographical Sketch Format Page of the PHS 398 and follow the PHS 398 instructions. 9. Biographical Sketches of All Professional Personnel and Pilot Investigators: Use the Biographical Sketch Format Page of the PHS 398 as above. This section should include all professional personnel who are listed with a percent effort, including consultants and members of the External Advisory Committee. Biographical sketches are also required for those who are listed in the research base. Arrange the biographical sketches alphabetically. These pages should not be duplicated in the individual component cores or pilots. 10. Complete List (or Table) of Participating Faculty/Members of the Center and the External Advisory Committee: List members alphabetically by name and include for each individual his/her degree, institution and department affiliation or equivalent, and research or other interest (e.g., research area, training, or education). 11. Resources: Using the Resources Format Page in the PHS 398 application kit, describe the relevant resources. 12. Overview of the Center and Description of the Research Base: This section is limited to 25 pages. The Specific Aims should state concisely the scientific area of inquiry that will serve as the focus for the Center, and the overall objectives of the Center. The Background and Significance section should include a critical review and synthesis of relevant research, theory, and methods to establish the scientific and public health significance of the proposed Center's objectives as described under Specific Aims. It should also provide a detailed rationale and justification for the proposed scientific area of inquiry with emphasis on how the institution will benefit from the proposed Center. Plans to develop productive collaborations among Center investigators should be highlighted, and criteria for designating an investigator as a Center participant (investigator) should be defined in terms of the responsibilities and privileges associated with a Center investigator. The justification for continuation of an existing Center should also be included in this section. The Preliminary Studies section should provide a detailed description and discussion of funded research projects that constitute the proposed Center's Research Base, and indicate how these studies support the selected scientific theme. It is helpful to present the Research Base studies in table format, specifying for each funded study (a) the title and grant number, (b) funding organization, (c) period of committed support, (d) direct costs for the project period, (e) current year annual direct costs, (f) names and institutional affiliations of the principal investigator and co-investigators, and (g) principal investigator's percent of committed effort. The Research Base studies and related resources should be described and discussed in sufficient detail to support an evaluation of their (a) relevance to the scientific area of inquiry, and (b) strengths and limitations as a scientific foundation for pursuing the Specific Aims of the proposed Center. Applicants may want to provide similar tables depicting pending support for research projects related to the scientific area of inquiry and current support for research projects unrelated to this theme. The focus and interrelationships of ongoing research and research interests for Center investigators should be documented. The Overview should also include a description of the qualifications of the Center Director. 13. Administrative Core: Provide a Detailed Budget, a Budget for Entire Proposed Project Period, and Budget Justification for the Administrative Core: Use Form Pages 4 and 5 of the PHS 398 application kit. The narrative section is limited to 25 pages. Provide a detailed description and discussion of the objectives, functions, organizational infrastructure, administrative procedures, key personnel (including the Core Director), and resources of the Administrative Core within the context of the overall Center. The description should depict the relationships and lines of authority by appropriate officials; committee structures and membership; and plans for assistance of a business official for fiscal matters. A diagram of the interactions to be fostered by the Center is useful in depicting proposed interrelationships and collaborations among institutional resources. Provide a general overall description of facilities and institutional commitment, including letter(s) of institutional commitment, and if applicable, a letter from the General Research Center Director. The composition and functions of the External Advisory Committee should be delineated. Also, describe the criteria, methods, and other components of the comprehensive evaluation plan for the Center. 14. Economics Core: Provide information modeled after the instructions above. 15. Additional Mandatory Core: Provide information modeled after the instructions above. 16. Optional Core(s): Provide information for any optional core modeled after the instructions above. 17. References: Follow the directions and instructions provided in the PHS 398 application kit. 18. Letters of Support: Provide letters of support. 19. Consortium/Contractual Arrangements: Follow the directions and instructions provided in the PHS 398 application kit. 20. Checklist: Use Checklist Form Page in the PHS 398 application kit. 21. Appendix Material: Follow the directions and instructions provided in the PHS 398 application kit. 22. Personal Data on Principal Investigator/Program Director: Use Personal Data Form Page in the PHS 398 application kit. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION: 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 must be sent to: Heidi Steele Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road. N.E., Mailstop D-50 Atlanta, GA 30333 Telephone: (770) 488-8612 FAX: (770) 488-8615 Email: HSteele@cdc.gov APPLICATION PROCESSING: Applications must be received on or before 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. 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. Upon receipt, applications will be reviewed for completeness by Center for Scientific Review, NIH, and for responsiveness by the Office of Public Health Research, CDC. Incomplete applications and applications that are not responsive to the eligibility criteria will not be reviewed. Applicants will be notified that their applications did not meet submission requirements. PEER REVIEW PROCESS 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 CDC in accordance with the review criteria stated below. CDC uses a peer review process modeled after that of the NIH, including a streamline review process, essentially as spelled out in the website located at: http://www.csr.nih.gov/REVIEW/streamln.htm As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score. o Receive a written critique. Applications in the upper half will receive a secondary review by the secondary review committee. REVIEW CRITERIA The goals of CDC-supported research in Centers for Excellence in Health Promotion Economics are 1) to explore economic priorities, barriers and solutions to developing, evaluating, and implementing health promotion guidelines, recommendations, programs and policies; and 2) to evaluate the cost effectiveness of such policies and programs. Health promotion policies and programs focus on creating environments and developing behaviors that result in lowering the risk of disease, injury, and disability. By promoting health and preventing disease, injury, and disability, people are given the opportunity to achieve their expected lifespan with the best possible quality of health in every life stage. In the written comments, reviewers will be asked to give careful consideration to the information in the SPECIAL REQUIREMENTS and CORE sections of the RFA and the review criteria listed below in order to judge the likelihood that the proposed Center will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Overall Center Grant Application 1. The overall scientific merit and the potential of the Center for making a significant contribution to achieving the goals of CDC. 2. The scientific gain from linking the research projects in a Center grant, i.e., the degree of interrelatedness and synergism among the components of the Center. 3. The qualifications of the Center co-Directors and other key investigators and the commitment of participating investigators to a common goal, to the science focus, and to collaboration. 4. The adequacy of the available resources and the quality of and potential for the research environment. 5. The commitment of the institution to the Center in terms of space, resources, administrative authority, and other necessary support, e.g., donated faculty time, use of equipment, and the extent to which the Center is recognized as a major element within the organizational structure of the institution. 6. The plans for developmental activities, including recruitment and expansion, insofar as these are justified by the proposed research program. 7. Evidence of the extent to which the planning, organization, structure, and design of the proposed Center and activities reflect a genuine collaboration within and across disciplines. 8. Appropriateness of the requested budget for the work proposed. Research Base 1. Focus and depth of funded investigations that are currently in progress. 2. Presence of current and emerging collaborations and interactions among investigators with common research interests within the area of scientific inquiry, and among the investigators within the research base. 3. Impact that funded investigators have made in their respective fields, as indicated by publications and other factors. 4. The qualifications, experience, and commitment of the Center investigators responsible for the individual research projects, and their willingness to collaborate with each other. 5. The appropriateness of the investigators as participants of the Center, and whether their activities warrant core support. Administrative Core 1. The adequacy of the Administrative Core to manage the overall activities of the Center. 2. The appropriateness and relevance of the proposed Core and the modes of operation, facilities, and potential for contribution to ongoing health promotion economics research. 3. Appropriate justification for the Core, including the duplication of existing resources or services and anticipated future use of the Core. 4. The qualifications of the Director of the Administrative Core. 5. The adequacy of the multiple aspects related to the administrative structure for the Center, including the provision of scientific and administrative leadership for the Center; strategies to promote scientific planning, interaction, implementation, and evaluation; and arrangements for the fiscal management of the grant. 6. The proposed composition and functions of the Executive Committee to support the proposed activities of the Center. 7. The proposed composition and function of the Advisory Committee to support the proposed activities of the Center. Other Individual Cores 1. The appropriateness and relevance of each proposed core and the modes of operation, facilities, and potential for contribution to ongoing health promotion economics research. 2. The qualifications of the Director of each core. 3. The relevance and importance of the core to advance the scientific area of inquiry. 4. Evidence of collaborative and/or interdisciplinary research. 5. The appropriateness of the justification for each core. Considerations include the duplication of existing resources or services and anticipated future use of each core. 6. The suitability of the facilities for the proposed research, including the availability of required special resources. 7. The inclusion of community representation as part of the Advisory Committee for the Health Disparities Core (if included). ADDITIONAL REVIEW CRITERIA In addition to the above criteria, in accordance with DHHS policy, all applications will also be reviewed with respect to the following: 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. This will not be scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to address the CDC policy requirements regarding the inclusion of women, racial and ethnic groups (and subgroups), as appropriate for the scientific goals of the research. Review criteria include: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: CDC expects researchers who are supported by CDC funding to make their data available for analysis by other public health researchers and include a data sharing plan in their application. CDC requires that mechanisms for, and costs of, data sharing be included in contracts, cooperative agreements, and applications for grants. CDC reviewers must check whether applications for CDC funds include mechanisms for, and costs of, sharing data. The costs of sharing or archiving data may be included in the amount of funds requested in applications for first-time or continuation funds. Applicants for CDC funds who incorporate data release into their study designs can (1) readily and economically set up procedures for protecting the identities of research subjects and (2) produce useful data with appropriate documentation. Awardees who fail to release data in a timely fashion will be subject to procedures normally used to address lack of performance (e.g., reduction in funding, restriction of funds, or grant termination). Researchers who contend that the data they collect or produce are not appropriate for release must justify that contention in their applications for CDC funds. 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. CDC’s policy is available at: http://www.cdc.gov/od/ads/pol-385.htm BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT SCHEDULE Letter of Intent Receipt Date: May 24, 2004 Application Receipt Date: June 21, 2004 Earliest Anticipated Award Date: September 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS For full explanation of additional federal citations required for applications to this RFA see: http://www.cdc.gov/od/pgo/funding/ARs.htm HUMAN SUBJECTS PROTECTION: Federal regulations (45 CFR Part 46) 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 INCLUSION OF WOMEN AND MINORITIES IN PUBLIC HEALTH RESEARCH: It is the policy of CDC to ensure that individuals of both sexes and the various racial and ethnic groups will be included in all CDC-supported studies involving human subjects, whenever feasible and appropriate. Furthermore, it is CDC policy to identify significant gaps in knowledge about health problems that affect women and racial and ethnic minority populations and to encourage studies which address these problems. Policy available in the Federal Register volume 60 number 179, September 15, 1995, page 47948-51. 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 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. Guidance is available at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA 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). 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 CDC GRANT APPLICATIONS OR APPENDICES: All applications and proposals for CDC funding must be self-contained within specified page limitations. Unless otherwise specified in a CDC 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 CDC 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.healthypeople.gov/. AUTHORITY AND REGULATIONS: Awards are made under authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This RFA is not subject to the intergovernmental review requirements of Executive Order 12372. 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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