EXCELLENCE IN PARTNERSHIPS FOR COMMUNITY OUTREACH, RESEARCH ON HEALTH DISPARITIES AND TRAINING (PROJECT EXPORT - ESTABLISHING COMPREHENSIVE CENTERS) RELEASE DATE: February 21, 2003 RFA: MD-03-003 (See modification in RFA-MD-06-002) National Center on Minority Health and Health Disparities (NCMHD) (http://www.ncmhd.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.307 LETTER OF INTENT RECEIPT DATE: March 28, 2003 APPLICATION RECEIPT DATE: April 22, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) 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 The National Center on Minority Health and Health Disparities (NCMHD) invites applications for establishing comprehensive centers (P60) under a continuing program for Project EXPORT: Centers of Excellence, Excellence in Partnerships for Community Outreach, and Research on Disparities in Health and Training. This centers of excellence program was authorized by the Minority Health and Health Disparities Research and Education Act of 2000 and is in support of the Department of Health and Human Services initiatives to address and ultimately eliminate health disparities. These P60 applications will focus on health disparities research, community outreach, and training. Two other announcements inviting applications for Project EXPORT using the (P20) Exploratory Planning Grant (RFA MD-03-002) and the (R24) Resource-Related Research Project (RFA MD-03-001) award mechanisms are presently available. A comparison of the requirements for submitting, and the unique characteristics for R24, P20 and P60 applications, can be found at: http://www.ncmhd.nih.gov. The P60 center grant awards will provide a mechanism by which research- intensive institutions can strengthen their research and training infrastructure for minority health and health disparities research and training. They will also provide resources for the development of innovative partnership models between other academic institutions and community groups/organizations. Research that explores a broad array of determinants of disparities in minority health and health disparities is encouraged as well as that which addresses a full range of health promotion approaches with the prevention or reduction of health disparities. For further information, refer to the section on eligibility. These P60 centers may be established independently by eligible institutions, through partnerships between minority serving and other designated institutions, or between designated and non-designated institutions with substantial existing federal research support and/or research infrastructure as reflected in a 2002 report on research institutions (http://thecenter.ufl.edu/research_data.html). NON- DESIGNATED INSTITUTIONS MUST BE INVOLVED, HOWEVER, IN PARTNERSHIPS WITH DESIGNATED INSTITUTIONS TO PARTICIPATE IN PROJECT EXPORT. Definitions for designated and non-designated institutions are provided in a later section of this RFA. The objectives of Project EXPORT include but are not limited to: 1) Promotion of the conduct of interdisciplinary research aimed at reducing disparities in health status; 2) Provision of a framework or infrastructure for encouraging multidisciplinary collaborations among biomedical, bio-behavioral and social scientists and among institutions, specifically those located in areas where members of health disparity groups comprise a significant percent of the population; 3) Building research capacity and infrastructure for health disparities research in minority serving and other designated institutions; 4) Promotion of the participation of health disparity groups in biomedical and behavioral research and prevention and intervention activities. The funding support for Project EXPORT Centers is intended to be catalytic in terms of providing opportunities for investigators from multiple disciplines to interact and develop new approaches for addressing disparities in health outcomes and for identifying risk factors for disparities in health status. TECHNICAL ASSISTANCE WORKSHOPS The NCMHD will conduct one technical assistance and information-sharing workshop, in Washington, DC (March 27, 2003). This workshop will allow applicants and NIH staff to discuss and clarify any issues or questions related to this application. Please inform NCMHD staff of the anticipated numbers of attendees by contacting Dr. Teresa Chapa via email (chapat@od.nih.gov), or by telephone (301-402-0050). To accommodate individuals who cannot attend, a summary workshop will be posted on the NCMHD home page at: http://www.ncmhd.nih.gov. RESEARCH OBJECTIVES Background The mission of the National Center on Minority Health and Health Disparities (NCMHD) is to promote minority health and to lead, coordinate, support, and assess the NIH effort to reduce and ultimately eliminate health disparities. In this effort, the NCMHD supports basic, clinical, social, and behavioral research; promotes research infrastructure and training; fosters emerging programs; disseminates information; and reaches out to minority and other health disparity communities. Although the diversity of the population in contemporary America is one of its greatest assets, the richness of this feature is overshadowed by the reality of the disproportionate burden of disease and illness that is borne by racial and ethnic minority populations and the rural and urban poor. Compelling evidence of the disparate health status of America's racial and ethnic minority populations and the economically disadvantaged is documented in the form of shorter life expectancies and higher rates of cancer, birth defects, infant mortality, asthma, diabetes, cardiovascular disease, and stroke. Other areas in which racial and ethnic minorities and the medically underserved suffer a disproportionate burden of morbidity and mortality include: HIV Infection/AIDS, autoimmune diseases such as lupus and scleroderma, oral health, sexually transmitted diseases, disease burden associated with mental disorders, drug use associated mortality, and viral borne diseases such as hepatitis C. While studies cannot delineate with certainty why health disparities exist, data suggests that differential incidences of disease and health outcomes result from the interaction of a plethora of factors in complex and unsuspecting ways. Observations and anecdotes provide clues about the etiology of the disproportionate burden of disease and illness, but it has only been through rigorous population and epidemiologic research that the medical community has been able to reasonably discern the extent of the healthcare crisis. We are now poised to more completely define the scope of the problem and begin the process of identifying and evaluating new approaches to mitigating disparities in health. Clearly, the soundest investment that can be made for the present and immediate future is a strengthened commitment to research, research training, and enhanced community involvement aimed at elucidating the etiology of health disparities, developing new diagnostics and treatment and prevention strategies, and the full implementation of such. Project EXPORT is central to NCMHD's investment strategy for addressing disparities in health status. Consistent with the goals of the trans- NIH Strategic Plan, EXPORT Centers will focus on research aimed at reducing and eliminating health disparities, improving research capacity, and providing outreach and education. In the first year of Project EXPORT Centers of Excellence Program, NCMHD supported the establishment of 6 Resource-Related Research Projects, (R-24), 9 Exploratory Planning Grants (P-20), and 11 (P-60) Comprehensive Center Grants. This announcement is intended to expand the Centers of Excellence Program to include all geographic regions of the US and its territories and to ensure the establishment of centers that focus on disparities in health status for all health disparity populations, including African Americans, American Indians and Alaska Natives, Asian Americans, Hispanic Americans, Native Hawaiians, Pacific Islanders and other medically underserved populations (i.e., socioeconomically disadvantaged individuals in rural and urban areas). Research Topics for Consideration The following sections provide examples of potential research directions and endeavors. The examples are not exhaustive and do not define areas of mandated research. Research Themes Project EXPORT Centers of Excellence Programs should reflect the following research themes. o Discoveries of the biological underpinnings of disparities in health status. o Creating healthy communities with a focus on identifying environmental determinants of health disparities. o Empowering community based organizations for participatory research. o Prevention First! In addressing and eliminating acute and chronic diseases and conditions. o Exploring health promotion and disease prevention across the life span and in all settings: the home, school, community, workplace, and faith-based settings, all from a multidisciplinary perspective. Research Areas of Emphasis and Scope The DHHS special emphasis areas are a priority, and investigators are encouraged to design studies using the following research methodologies/ strategies: o Population-based studies with a focus on the DHHS special emphasis areas: cardiovascular disease, stroke, cancer, diabetes, HIV/AIDS, infant mortality, and mental health. o Within and between-group comparative studies designed to identify similarities and differences in physiological processes at the sub-population level. o Studies that use ethnographic methods to articulate the interacting effects between the economy, the community, the household, and the individual with the goal of operationalizing psychosocial and societal experiences in a quantitative manner such that their impact on physiological/psychological processes can be assessed. Health Promotion/Prevention Research Objectives/Priority Areas o Communications research – how to reach racial/ethnic minority and other medically underserved populations with messages that will lead to positive behavioral and health changes. o Translational research – successfully incorporating research into health promotion/prevention programs or policies in communities, schools, businesses, families, prisons, etc. o Epidemiologic studies – focusing on assessing and advancing understanding of health disparities in local communities o Prevention/Interventions research within health disparity populations (African Americans, American Indians and Alaska Natives, Asian Americans, Hispanic Americans, Native Hawaiians, Pacific Islanders, and other medically underserved populations (including the rural and urban poor), and geographical regions (Appalachia, U.S.-Mexico Border region, Mississippi Delta region, and Tribal Communities). o Cultural sensitivity/competency, and its role in health promotion/disease prevention. o Interaction of culture and other variables on issues such as recruitment into research studies and clinical trials, utilization of services, adherence to lifestyle and behavioral changes; and understanding individual cultural belief and expression within a multicultural setting. o Development of measures, instruments, and research designs to facilitate health disparities research. Capacity Building and Infrastructure Objectives o Development of a cadre of culturally competent researchers with expertise in minority health promoting and supporting research capacity-building activities at designated institutions. o Increase the number of underrepresented racial/ethnic minorities with careers in the biomedical, bio-behavioral, and social sciences research. Community Outreach Objectives o Engaging communities and their community-based organizations in research and related activities that address disparities in health status o Facilitating the dissemination of culturally sensitive health information. o Engaging institutions in K-12 Science Education activities. Other topics: o Interdisciplinary minority health and other health disparities research, including basic, clinical, behavioral and social sciences research to advance the understanding of disease/disability development and progression. o Research that improves approaches for diagnosis, prevention, and treatment. o Potential pathways to disparities in health outcomes, including but not limited to environmental exposures, genetic variations and/or other underlying biological, ethnic and familial factors. In particular studies identifying the biological underpinnings of differential responses to therapies (i.e., hypertension, diabetes, renal transplantation, depression) and/or the differential prevalence of disease. Also included are studies of the specific mode of transmission and/or natural history of diseases such as hepatitis C in minority groups and potential differences related to virologic infection, particularly in terms of viral genotype, host differences, and/or differential responses to antiviral therapies. o Development of methodological tools for disentangling the impact of biologic factors and socioeconomic status on health. o Epidemiological studies of the incidence and prevalence of disparities in health status among individuals living in different geographical regions of the US, in particular, Appalachia, U.S. –Mexico Border region, Mississippi Delta region, and Tribal Communities. And studies designed to investigate factors contributing to the excess morbidity and mortality associated with living in such regions. o Developmental influences across the life span, specific health behaviors, discrimination in health processes, psychosocial, socio-cultural, and socioeconomic (SES) related factors, such as differential access to health care. Health processes include the technical and interpersonal activities pertaining to disease prevention, diagnosis, and treatment that go on between patient and practitioner. Project EXPORT Research Infrastructure EXPORT Center applications should be organized into discrete components that comprise a proposed overall program of research. Take note of those cores and components that are mandatory. o Administrative Core -- Mandatory 15 -- page maximum The administrative core component plays a key role in the coordination and operation of the proposed EXPORT Center. Through this core, the Center director provides substantive leadership as well as manages the administration of the budget. This core should be described in sufficient detail to assure that all proposed components and related activities would function optimally and in an interactive, synergistic manner. o Research Component -— Mandatory -- 15-page maximum for each full research project proposed Each full research project must be a highly focused area of investigation and may include several investigators under the direction of a project director. Each proposed research project will be reviewed on its own merit. Thus, each project must be described separately and include an individual budget. Individual research projects must be thematic, highly focused, and interrelated so that they collectively contribute to the goals of the Center program to a greater extent than if the research undertaken under individual components were pursued separately. Provide a clear description of each proposed project, including major goals and objectives as well as how it integrates with the other Center components in relation to the overall EXPORT Center program. Pilot projects may be included in this section, but are not mandatory. The purpose of pilot projects is to provide the Center with a flexible means of developing and exploring new research activities or directions and unique scientific opportunities that could evolve into independently funded research projects. Such projects must be in a separate pilot project component that incorporates all of the pilot studies of the proposed Center grant. While the specific number of pilot projects to be proposed is at the discretion of the applicant, all proposed pilot projects need not be ongoing at any one time, but may be phased in at different points during the life of the proposed Center grant. It is recognized that the relative priority or need for specific pilot projects may change over the course of time. While the Center's framework for the management of pilot funds and the mechanism for operating the program are left to the discretion of the Center, the application must provide specific information to enable adequate scientific evaluation by a peer review committee. (The descriptions of all proposed pilot research projects must be limited to 5 pages each. This is in addition to the recommended 15-page limited for describing each research core component.) o Community Outreach and Information Dissemination component -- Mandatory -- 15-page maximum The mission of the Community Outreach and Information Dissemination Component is to integrate the EXPORT Centers into the local communities as a disease prevention and health and science education resource. Accordingly, there is a three-fold focus: 1) development and dissemination of culturally sensitive health information – directly related to the research of the Center or general health information presented in a culturally sensitive manner; 2) encouraging and equipping the community for potential participation in clinical studies and for partnering in the conduct of evidence based disease prevention and intervention activities; and 3) sponsorship of science education outreach activities (e.g., K-12 science programs with area middle schools and/or high schools). EXPORT Centers may develop exploratory programs for disseminating minority health and health disparities research information, as well as sponsor activities that encourage community participation in research either as study participants or that equip community based organizations for partnering in and/or conducting disease prevention and/or intervention activities. In particular for information dissemination purposes, the audiences should include health care students and professionals, community based organizations and researchers at the host institution as well as investigators at other institutions. Information transfer activities may include, but are not limited to activities such as training programs, short courses, telemedicine, presentations at professional meetings and publications. Information transfer refers specifically to activities that involve interactive exchanges between Project EXPORT staff and the community. With respect to equipping health disparity communities to develop and manage their own culturally sensitive/competent programs for educating their populations and/or participating in prevention and intervention activities, the focus could be on addressing risk factors for disease, chronic disease management, screening, prevention, and decision making with respect to available therapeutics. Such activities may require a substantial portion of the first year for planning and development with actual implementation beginning near the second year and continuing in subsequent years. Plans to evaluate the success and/or effectiveness of the proposed community outreach/information dissemination should be described, with emphasis on the impact of the proposed activities on knowledge, attitudes, and/or behaviors. Note that it is expected that considerable development of the Community Outreach Component may be ongoing in year one of the project period with full implementation targeted for year two. o Training Component -- Mandatory -- 15-page maximum Training activities may be provided at the undergraduate, graduate, post-doctoral, and junior faculty level or a combination of two or more of the aforementioned levels. Undergraduate/Graduate Students. Training components for students may include establishing academic term and/or summer training opportunities. For consortia arrangements, in particular, new research training programs might provide graduate students the opportunity to fulfill their research requirements in research laboratories at the partner institution. Post-Doctoral Training. Training components may also support post- doctoral training for individuals that have earned the doctorate degree or equivalent, and who are additionally members of racial and ethnic minority groups, or other health disparity subpopulations. Including opportunities for postdoctoral training within Project EXPORT will fulfill an important gap. Junior Faculty at Minority Serving Institutions (MSIs)- With respect to faculty at MSIs, mentored research components may be developed to provide assistance in learning new methodologies or to encourage faculty participation. The applicant institution and its partners must demonstrate or give reasonable assurances that it has: the capacity to train predoctoral and/or postdoctoral students for careers in biomedical, behavioral, epidemiological or health services research, and posses the capacity to conduct continuing education programs on the Center's designated research theme in the medical, behavioral, epidemiological, or health service fields. Further, the research training core is expected to: develop, implement and evaluate research development activities related to conducting health disparities research for participants at all partnering institutions, provide training on issues related to cultural competence; increase the number of potential investigators from racial and ethnic minority and other health disparity groups, and identify and facilitate interdisciplinary collaboration to promote the conduct of health disparities research. For partnerships and consortia, in particular, training initiatives should represent true collaborations that function across institutional boundaries. o Shared Resource Core(s) -- 15-page maximum Shared resource cores are intended to enhance opportunities for investigators at the Center to take advantage of new technologies that could enhance and broaden their research initiatives. While, research is not conducted as part of the shared resource core, quality assurance activities that evaluate the operation, resources, quality and utilization of the core and are directed at problem identification and improvement of core functioning are appropriate. Some examples of support that are typically provided in shared resource cores include: a) technology that implements automation of large batch preparations; b) tissue and/or cell culture facilities; c) complex instrumentation, (e.g., electron microscopy, mass spectrometry, electrophysiology); d) animal care and preparation; e) service and training; f) patient coordination; and g) information processing, data management, and statistical services; and h) telehealth development and use. In collaborative partnerships and/or consortia arrangements, priority must be given to locating newly developed shared resource core activities at predominantly minority serving institutions. o Minority Health and Health Disparity Education Component -- 15-page maximum An educational component could focus on efforts to augment existing or create new curricula among partner institutions that would apprize and culturally sensitize undergraduates, graduate students, or postdoctoral trainees in research, medicine, or public health of the need to reduce and eliminate disparities in health status among the nation's ethnic and racial minority groups, and other medically underserved populations. A successful first effort may result in an R25 education grant. It is anticipated, however, that such efforts will later lead to institutional commitments to make these curricula an inherent component of their educational systems. MECHANISM OF SUPPORT This RFA will use NIH series P60 comprehensive center award mechanism. 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 NIH peer review procedures. The anticipated award date is September 29, 2003. FUNDS AVAILABLE The NCMHD intends to commit approximately $6.0 million in FY 2003 to fund five to six new grants in response to this RFA. An applicant may request a project period of up to five years and a budget for DIRECT COSTS of up to $815,000 per year. In addition, Facilities and Administrative (F & A or indirect) costs will be provided at the applicant's negotiated rates. 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 award will also vary. Although the financial plans of the NCMHD 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. ELIGIBLE INSTITUTIONS You may submit an application if your institution meets the Special Requirements listed below: o Public or private institution (i.e. University, College, Hospital and/or laboratory). Foreign institutions are not eligible. For-profit or non-profit state, local and faith-based organizations, and Tribal governments must partner with eligible institutions in order to participate in this RFA. Additional requirements pursuant to the statute that authorized this program can be found in the section SPECIAL REQUIREMENTS. 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 DEFINITIONS The definitions below are intended to clarify concepts that are expressed in this RFA. APPLICANT INSTITUTION: The applicant institution is the entity at which the EXPORT Center will be physically and/or integrated into its administrative structure. The Director must have his/her primary appointment at the applicant institution. COLLABORATING INSTITUTION: The collaborating institution is the institution with which the applicant institution has partnered. PREDOMINANTLY MINORITY SERVING INSTITUTION: A predominantly minority serving institution is an academic, health care or research institution with an enrollment and/or faculty that consists predominantly of racial and ethnic minorities. DESIGNATED INSTITUTION: Pursuant to Public Law 106-525, a designated institution is an intuition of higher learning that has a history of enrolling and graduating racial and ethnic minority and socioeconomically disadvantaged students from their degree programs. The recruitment of racial and ethnic minority faculty and staff is also a priority at such institutions. Operationally, a designated institution is one that has: o Been effective in assisting students from racial and ethnic minority and other health disparity populations to complete a program of study or training and receive the advanced degree(s) offered. o Made significant efforts to recruit and enroll minority and other health disparity population students into and graduate from the institution, which may include providing means-tested scholarships and other financial assistance as appropriate. o Made significant recruitment efforts to increase the number of minority or other members of health disparity populations serving in full-time faculty or administrative positions at the institutions. NON-DESIGNATED INSTITUTION: A non-designated institution is considered as any institution of higher learning that does not have a record of recruiting racial and ethnic minority and other health disparity population students or graduating such students from their degree programs. HEALTH DISPARITY POPULATIONS: African Americans, Alaskan Natives, American Indians, Asian Americans, Hispanic Americans, Native Hawaiians, Pacific Islanders, and other medically underserved populations, which includes socioeconomically disadvantaged individuals in rural and urban areas. (P.L. 106-525) PARTNERSHIP AND CONSORTIUM ARRANGEMENTS: When a grant application includes research activities that involve more than one institution it is considered a partnership or consortium effort, depending on the number of institutions involved. Such activities are encouraged in FY 2003. DEMOGRAPHIC GOALS Project EXPORT has a grass-roots strategy with a focus on matching the needs of the community with the strengths of local institutions. Therefore, establishing EXPORT Centers and related programs within geographic areas with specific demographic characteristics is an important emphasis. For example, to ensure that geographical regions with the greatest disparities in health status are given priority, a minimum of one of the following must also apply with respect to the applicant institution and/or one or more members of a consortium: o Be located within a metropolitan statistical area (MSA) where the density of racial and ethnic minorities within the general population is equal to or exceeds: 19 percent for Hispanic Americans or African Americans respectively, 10 percent for Asian Americans, Native Hawaiian, and Pacific Islanders, or 2 percent for American Indians and Alaskan Natives. In addition, the overall poverty rate within the geographic region to be served by the center must equal or exceed the national average of 11.3 percent. (Overview of Race and Hispanic Origin, Census 2000 Brief, Elizabeth Grieco and Rachel Cassidy. http://www.census.gov/hhes/poverty/poverty00/tabled.pdf OR o Be located within or near a Health Professional Shortage Area (HPSA) or within an officially designated area of underservice. For the purposes of this announcement a United States Department of Agriculture (USDA) designated HPSA is a geographical area having fewer than the generally accepted minimum number of clinicians (physicians, dentists and mental health workers) per thousand. A listing of the USDA fully medically served and underserved HSAs can be found at (http://www.hrsa.gov/grants/). An underserved area is a geographical region with a calculated score of 62 or less on the IMU (Index of Medical Underservice Scale). The IMU index is a weighted score derived from four criteria: ration of primary medical care physicians per 1,000 population, infant mortality rate, percentage of population below the federal poverty level, and percentage of the population 65 years and older (http://www.hrsa.gov/grants/). OR o Be located within a Department of Health and Human Service Region where the density of Native Americans and Alaskan Natives in the general population equals to or exceed 200,000. There are ten DHHS regions: http://www.hhs.gov/about/regions. American Indians and Alaska Natives generally reside in the greatest numbers in DHHS regions IV, VI, VIII, IX and X with the overall highest density in regions VI (Arkansas, Louisiana, New Mexico, Oklahoma, and Texas) and IX (Arizona, California, Hawaii, Nevada, Pacific Basin, and Guam). See: http://factfinder.census.gov/servlet/BasicFactsServlet. Any institution that meets the above criteria may form a consortium with Tribal Colleges and Universities (TCUs), tribal health programs or with non-designated institutions. Non-designated institutions are institutions of higher learning that do not meet the criteria outlined above but which have substantial federal research support and/or research infrastructure as reflected in the report on research institutions: http://thecenter.ufl.edu/research_data.html. For a listing of HBCUs and HSIs see the following website address: http://www.sciencewise.com/. A listing of TCUs may be found at: http://www.humboldt.edu/~hsuitepp/college.html. Note that while partnerships among designated institutions are strongly encouraged, involvement in a partnership is not an absolute requirement for participation in Project EXPORT. Also note that pursuant to Public Law 106-525 designated institutions are intuitions of higher learning that have a history of enrolling and graduating racial and ethnic minority and other socioeconomically disadvantaged students from their degree programs. The recruitment of racial and ethnic minority faculty and staff is also priority at such institutions. ALLOWABLE COSTS IN EXPLORATORY EXPORT CENTER APPLICATIONS Projects/Cores/Components: The minimum acceptable combined number of cores and components is four, and the maximum acceptable number of cores and projects is eight. Each proposal must include an Administrative core, a Research component (full and pilot projects), a Training component, and a Community Outreach component. The total number of Center Components should reflect the ability of the applicant institution(s) to carry out the proposed activities. An applicant proposing activities and usage of funds beyond his/her capability will not fare well during the review process. o Administrative Core--Mandatory. This component may include the costs of recruitment packages for key leadership positions in year one and education activities for faculty and staff; salaries of personnel responsible for management of the Center, supplies, travel, special consultation, program enrichment activities for investigators and staff such as special lectures, visiting scientists, symposia, seminars, workshops, etc., and costs related to dissemination of research information to the scientific community and lay public. Funds also may be requested for the allowable indirect costs of the applicant organization(s). In addition, costs of advisory committee and consultants may be included in the administrative core. Consultants for specific components should be included in the budgets for those components. o Research Component(s) -- Mandatory. A combination of full and pilot projects can be requested. Partial salary for essential personnel, and other costs essential for the improvement of research infrastructure. Seed money and start-up funds to support new, innovative pilot projects can be requested. Like a small grant, these funds should support activities that would serve as the basis for the development of a larger research grant applications. The budget should be submitted for the pilot project component as a whole for each year in which pilots are proposed. For years 01 and 02, this budget will reflect costs of pilots proposed in the application. For years 03-05, the budget will estimate cost based on the number and kind of work to be pursued. Note that the funds for pilot projects are not intended to supplement ongoing research projects. o Training Component -- Mandatory. Support for students, including an allotment for research supplies, salary support for the core director. o Community Outreach and Information Dissemination component -- Mandatory. Salary support, support for prevention/intervention activities, as well as educational outreach, etc. o Shared Resource Core. Funds for the development of a shared resource core should be requested in its individual budget. In the first year of the grant, substantial funds may be allocated in the budget of the administrative core for recruitment packages for core directors. o Mentoring Component. Support for students, including an allotment for research supplies, salary support for the core director. o Minority Health and Health Disparity Education Component. Costs related to the development and implementation of educational activities, partial salary support, etc. OTHER SPECIAL REQUIREMENTS Each exploratory EXPORT Center application must include and/or address the following: o Letters of commitment from the leadership of each partnering institution. The letters should indicate full support for this activity and specify what efforts will be made to ensure the success of these planning activities. Such efforts might include protected faculty time, provision to recruit new faculty, space and facilities for the proposed new projects/programs, capital improvements, etc. o Administrative structure -- A Center must be an identifiable organizational unit with an administrative structure and clear lines of authority that will facilitate coordination among Center personnel to assure maximum accountability and efficiency in Center operations. An applicant must designate an institutional official(s) to serve as principal investigator for the Center and/or as Director of the Center. The institutional appointment of the Center Director must provide sufficient authority to allocate space, personnel, and other resources essential to the Center. This individual must demonstrate the ability to organize, administer and direct the Center. The Director of the Center will have responsibility for planning and coordination of the Center program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of management and operation of the Center. o Key professional staff such as directors of individual research components and shared resource core components of the Center should have the necessary training/experience to assure that the objectives and goals of the proposed activities will be achieved. Such persons must be independent investigators with productive research programs. If a director is not in place at the institution at the time of scientific review or award, a plan to recruit such an individual must be included in the application. If an institution has not appointed a permanent Center Director at the time of award, the making of an award pursuant to this RFA will take place at the discretion of the NCMHD director, in consultation with the NCMHD Advisory Council. o Budget for an annual meeting in Bethesda, Maryland with NCMHD staff o A Program Advisory Committee must be comprised of at least three to five scientists with national scientific reputations in their field; their expertise must be directly relevant to the scientific theme of the Project EXPORT activity. The advisory committee responsibilities include concept development, program planning, encouraging faculty development and mentoring, identifying resources, and evaluating progress toward stated goals. The committee will also review and approve candidates for replacement/substitute projects and investigators as required, before such requests are forwarded to NCMHD. The committee must meet at least twice per year and minutes are to be recorded and made available for review by NCMHD program staff responsible for Project EXPORT. o If a committee other than the Program Advisory Committee is included, such as a proposed Program Executive Committee, specific plans regarding committee selection and function should be provided in the application. An Executive Committee usually consists of the heads of all cores, representatives from the partnering institution (if applicable), and appropriate business officials. The function of such a committee would be to assist the Director and Co-director with decisions pertaining to the allocation of funds, the identification and selection of key personnel, and the planning and execution of the center activities. o Planning/Evaluation. There must be a common planning and evaluation process described in the application. This process will be responsible for planning and implementing internal processes (e.g., workshops that identify areas of new opportunity, as well as for strengthening, establishing and merging existing projects/programs). Internal processes must also have an evaluation and prioritization process in place for reviewing internal proposals for Pilot and full projects/programs, recruitment of research associates, new investigators and establishment of resources and infrastructure on the basis of their merit and potential to contribute effectively to achieving high priority goals and objectives. o Centers will be required to submit detailed annual progress reports including substantive information about research results to date, status of ongoing research, research plans for the next year, and any modifications in long-term research plans. Also required are reports of inventions, reports of expenditures, final reports, and other reports in accordance with NIH policy. o Facilities and Environment. Applicants should describe the facilities and environment. A description of the plans for accomplishing any needed enhancements should also be provided. Although not required, it is desirable for all Centers to have a commitment for sufficient contiguous space so that the Center has a high degree of cohesion and visibility. Reference facilities that provide access to relevant literature must be readily available. It is expected that such reference facilities will be the primary repository of additional reference materials that may be obtained through Center funding. Relevant support services, including adequate data processing facilities, must also be readily accessible within or through the institution. Assurances of such support must be included with the proposal. o Program management, coordination, communication, progress assessment, and quality control are typically responsibilities of the Director and are facilitated through the administrative core. The administrative core should be described in sufficient detail to assure that all proposed components and related activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of the administrative core. o The applicant may also designate a Scientific Director who will be responsible to the Center Director and provide direct supervision of the scientific and operational aspects of the research program. Such a person should be an individual who has established scientific credentials and who is capable of providing the leadership essential to the success of the center program. The Scientific Director will be responsible for assuring interaction and collaboration among scientists conducting research within the Center to facilitate a concerted approach to the research goals of the Center. The Scientific Director also will be responsible for the direct monitoring of ongoing research and for identifying with the assistance of colleagues research activities and educational activities to be expanded or decreased and needs for additional resources or reallocation of resources. If the Center Director also serves as the Scientific Director, his or her functions as Scientific Director should also be described. o Each EXPORT Center shall develop a 5-year strategic plan to be included in the application as an attachment. The research focus of the proposed Center's plan must reflect the health disparity priorities of the Department of Health and Human Services: infant mortality, diabetes, cardiovascular disease, stroke, cancer, HIV/AIDS, and mental health, as well as the programs and priorities of the NCMHD, and/or the overall priorities of the Trans-NIH Plan for Addressing and Ultimately Eliminating Health Disparities. The plan should also address research training goals, the institutions' plans to build on their/its strengths and capabilities to conduct minority health and health disparities research, and where applicable, address the needs of the partnering minority-serving institution(s) in furthering its goals. The Strategic Plan must highlight the role of the Program Advisory Committee in providing a written formal evaluation of the Center's progress based on a performance plan to be developed during the first year of the grant award. It is expected that the Program Advisory Committee would include recommendations for the EXPORT Center in its evaluation. o Annual Progress Report/Summary Report. The Program Director of the Center will prepare a progress report annually in addition to a Summary Report near the conclusion of the first five years of EXPORT Center activity. The Summary Report should contain, but not be limited to, the EXPORT Center description, findings regarding the effectiveness of the partnership experience, research findings and observations on the administration of the program. OTHER FUNDING SOURCES Research, dissemination of research information and training activities associated with the Center may receive additional funding from Federal sources as well as from State and local sources. The NCMHD expects and encourages the institution and scientists attracted to such Centers to seek and compete actively for additional funding. Research staff in funded Centers may submit applications for independent research project grants for support of research projects that do not overlap with their Center projects. RESTRICTIONS With respect to activities for which a Project EXPORT award is authorized to be expended, the Director of the Center may not make such an award to a designated research institution or consortium for any fiscal year unless the institution or institutions in the consortium, as the case may be, agree to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the level of such expenditures maintained by the institutions involved for the fiscal year preceding the fiscal year for which such institutions received such an award [P.L. 106-525 (Section 485F) (e)(1)]. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial/grants management issues. Direct inquiries regarding programmatic issues to: Tommy L. Broadwater, Ph.D. Acting Director, Division of Research and Training Activities, National Center on Minority Health and Health Disparities, National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 TEL: 301-402-1366 FAX: 301-480-4049 EMAIL: broadwat@od.nih.gov Direct your questions about financial or grants management matters to: Mr. Bryan Clark Grants Management Officer, National Center on Minority Health and Health Disparities, National Institutes of Health 6707 Democracy Blvd., Suite 800, MSC 5465 Bethesda, MD 20892-5465 Telephone: (301) 402-1366 Fax: (301) 480-4049 Email: Clarkb@od.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this 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 Center 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: Tommy L. Broadwater, Ph.D. Acting Director, Division of Research and Training Activities, National Center on Minority Health and Health Disparities, National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 TEL: 301-402-1366 FAX: 301-480-4049 EMAIL: broadwat@od.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grants 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: 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 copies of the application and five copies of any appendix material must be sent to: Tommy L. Broadwater, Ph.D. Acting Director, Division of Research and Training Activities, National Center on Minority Health and Health Disparities, National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 TEL: 301-402-1366 FAX: 301-480-4049 EMAIL: broadwat@od.nih.gov 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, however, such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCMHD. 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 NCMHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Receive a second level review by the NCMHD Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, 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 gender groups, 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 DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o OTHER REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: Evidence that the researchers and faculty of the partnering institutions worked closely together in the preparation of the application. Letters of support from senior faculty and/or institutional leaders were supportive of the planning activities. As applicable, the adequacy of provisions made for day-to-day oversight, coordination, support and logistical services needed to make the collaboration successful. Planning -- The adequacy of the different planning methods proposed by the institutions to fully explore areas of opportunity and to ensure highly interactive and integrated efforts between individual scientists (e.g., research project) and/or between faculty and scientists (e.g., training program, education program). The appropriateness and adequacy of the specific faculty and scientists identified to contribute effectively to each aspect of this planning effort. OTHER REVIEW CONSIDERATIONS Administrative Core o Adequacy of the administrative core to manage the overall planning activities. o Appropriate justification for the core, including the duplication of existing resources or services and anticipated future use of the core. o Qualifications of the Director of the Administrative core (if applicable), including the ability of the center director to provide the scientific an administrative leadership for the planning activities, strategies to promote scientific planning, interaction, implementation, and evaluation; and arrangement for the fiscal management of the grant. o Proposed composition and function of the Executive Committee to support the proposed activities. o The proposed composition and function of the external Advisory committee to support a proposed EXPORT Center. Pilot Projects o The scientific merit of the concepts for the proposed research and the importance of the information sought to the mission of the NCMHD. o The process for selecting the pilot/feasibility studies to be included in the planning activities. o How well the proposed research areas address minority health and health disparities. o The innovativeness and promise of the proposed methods to be used in the conduct of research. o The novelty or originality of the proposed research concepts. o The appropriateness and justification of the requested budget for the proposed planning activities. o The qualifications of the investigator that will lead the initiative to develop the research questions and/or plan feasibility studies. If required, areas in which investigators will be recruited. o Adequacy of plans to identify and address ethical concerns related to conducting health disparities research. Shared Resource Core o Need/justification for the core service/resource. o Scientific and ethnical merit of the service/resource provided. o Plans for resource allocation. o Quality control procedures. o Qualifications, experience, and commitment of the component director. o Adequacy of component director's time and effort. o Adequacy of the resources and environment. Research Training o Evidence of a strong commitment to and plans to help foster and facilitate the research career development of racial and ethnic minority students and other health disparity students and faculty. o The plans to facilitate and monitor the research career trajectory and productivity of participants at both members of the partner institution and where applicable at all members of a consortia. o Qualifications of the investigator that will lead the planning activities for research mentoring component. Community Outreach/Information Dissemination o Adequacy of plans for establishing, sustaining, and evaluating research-based prevention and intervention studies with targeted communities, if applicable. o Adequacy of plans for K-12 science education outreach, if applicable. o A plan for disseminating health disparities research findings to participants, community groups, and lay and professional audiences, if applicable. o The qualifications of the leadership of the planning activities for research outreach and dissemination. Overall Research Resource Related Developmental Activities o Evidence of collaborative and/or interdisciplinary research, and interdisciplinary approach of the Project EXPORT activity. o Adequacy of the available resources and the quality of the research or training environment. o The institutional commitment to the Project EXPORT planning activity in terms of space, resources, administrative authority, and other necessary support, e.g., donated faculty time, and the extent to which a proposed EXPORT Center would be recognized as a major element within the organizational structure of the institution. o The plans for developmental activities, including recruitment and expansion, insofar as the proposed research and/or training program justifies these. o The plans for the provision of protection of human subjects and the humane care of animals. o Appropriateness of the requested budget for the work proposed. o The adequacy of plans to include both genders, and if applicable, other health disparity groups, and children as appropriate for the scientific goals of the proposed research. Plans for the recruitment and retention of subjects will also be evaluated. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 28, 2003 Application Receipt Date: April 22, 2003 Peer Review Date: July-August 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 30, 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 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 P.L. 103-43). All investigators proposing research involving human subjects should read the Amendment NIH Policy and Guidelines on the 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 is 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. 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 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. 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 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: The authority for the centers of excellence program was provided in the statute that established the National Center on Minority Health and Health Disparities. Pursuant to Section 485F of the Minority Health and Health Disparities Research and Education Act of 2000, The Director of the Center shall make awards of grants or contracts to designated biomedical and behavioral research institutions…for the purpose of assisting the institutions in supporting programs of excellence in biomedical and behavioral research training for individuals who are members of minority health disparity populations or other health disparity populations. It is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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