CENTERS FOR RESEARCH TO REDUCE ORAL HEALTH DISPARITIES Release Date: September 30, 1999 RFA: DE-99-003 May 3, 2007 - This RFA has been reissued as (RFA-DE-08-008). National Institute of Dental and Craniofacial Research Health Resources and Services Administration National Institute of Child Health and Human Development National Institute of Nursing Research Centers for Diseases Control and Prevention Office of Research on Minority Health Office of Behavioral and Social Science Research Office of Research on Women"s Health Letter of Intent Receipt Date: July 17, 2000 Application Receipt Date: November 15, 2000 PURPOSE The National Institute of Dental and Craniofacial Research (NIDCR) along with the Health Resources and Services Administration (HRSA), the National Institute of Child Health and Human Development (NICHD), the National Institute of Nursing Research (NINR), the Centers for Disease Control and Prevention (CDC), the Office of Behavioral and Social Science Research (OBSSR), the Office of Research on Minority Health (ORMH), and the Office of Research on Women"s Health (ORWH) invites applications for research designed to lead to a reduction in health disparities among the peoples of the United States by focussing on craniofacial, oral and dental diseases, disorders and health. This Request for Applications (RFA) represents the natural evolution of philosophy in the previously funded Regional Research Centers for Minority Oral Health (RRCMOH) initiative. Receipt of an RRCMOH grant, however, is not a prerequisite for submission of an application in response to this RFA. The overall objectives of the Centers for Research to Reduce Oral Health Disparities (CRROHD) initiative are to support research that will lead to an understanding of the factors associated with health disparities as well as to support the development, testing and evaluation of interventions designed to reduce health disparities with a particular interest in oral, dental and craniofacial diseases and disorders. It is expected that each center will be a training and mentoring resource for developing and strengthening the biomedical, clinical and behavioral health research capacity of the nation by expanding research opportunities for scientists in underrepresented groups within the scientific workforce through required collaborations with minority institutions as well as through other career development activities. Although the overall focus of the initiative is on reducing health disparities in children and their caregivers, research proposed by individual centers may fit within the scope of the initiative by focussing on one aspect of issue (e.g., examining factors contributing to or reducing the health disparities of caregivers alone, assessing oral health status of children in specific SES/cultural/regional/community groups, collecting data and/or developing interventions that address a specific health disparity in a defined group) or they may address the full range of research possibilities (e.g., role of oral health of mothers and/or other family members in the health of neonates and children, access to health care issues as they related to the craniofacial, oral or dental health of children and their caregivers). The focus of this new center initiative is on reducing health disparities through basic, translational, clinical, patient-oriented health services and community-based research. It is envisioned that realization of this central focus will be accomplished through the development of knowledge that will lead to an understanding of biological, behavioral, psychological, anthropological, sociological and economic causes of health disparities in the United States. It is also envisioned that the new knowledge will lead to the design and testing of interventions that rely on and take advantage of the cultural competencies involved in the health of members of various groups. A major hallmark of the initiative is national research and training networks. These may be fostered by increased collaborations across the health professions (e.g., dentistry, medicine, nursing, pharmacy, behavioral and social sciences, public health) both within and between institutions as well as between the health professions and social services (e.g., State and Local health and health financing agencies) directed at health promotion. Finally, the initiative is inclusive with respect to populations of interest in that it spans the racially, ethnically and culturally diverse populations of our nation including populations of recent immigrants, individuals at all socioeconomic status (SES) levels, those from both rural and urban settings, and individuals who are medically challenged or compromised. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Centers for Research to Reduce Oral Health Disparities, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic for-profit and non- profit organizations, public and private, such as academic health centers, dental schools, universities, colleges, laboratories, units of State and Local governments, and eligible agencies of the Federal Government. It is expected that the applicant institution will have received support for research from NIH or other federal agencies. Although currently funded RRCMOH institutions are encouraged to apply for a CRROHD, prior receipt of a RRCMOH grant is not a prerequisite for applying for or receiving grant under the terms of this RFA. Applications from foreign institutions are not eligible but collaborations between domestic and foreign institutions may be scientifically necessary and justifiable. Applications from minority individuals, women, and persons with disabilities as principal investigators are strongly encouraged. To be responsive to this RFA, an applicant must propose collaborative affiliations with other entities. The collaboration can be with entities from within the parent institution as well as with other institutions and should be for the purpose of facilitating and addressing the scientific objectives of the proposed center. Collaborations may encompass colleges/schools/departments representing the entire spectrum of the health professions (e.g., dentistry, medicine, nursing, pharmacy, veterinary sciences, behavioral and social sciences) or academic institutions and State and Local health and health financing agencies (e.g., state Medicaid agencies and Children"s Health Insurance Programs). To be eligible for this initiative, each center is required to involve a partnership with one or more minority institutions (e.g., Historically Black Colleges and Universities, Hispanic serving institutions, Tribal Colleges and Universities). The applicant may be either a minority institution or a non-minority institution. Additional details about this aspect of the initiative are contained in the section titled "Center Characteristics." Regional proximity of the affiliated institutions is not required but, for a variety of reasons, may be an asset. However, such an arrangement may not be possible. In those instances, applicants are urged to provide compelling evidence of procedures and/or processes that will be used to overcome any potential problems associated with the geographical separation. MECHANISM OF SUPPORT The mechanism of support utilized will be the Specialized Center (P50) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant and collaborating institutions. However, consultation with NIDCR staff will be expected in the form of periodic site visits and annual meetings of center directors. Although this RFA is a one-time solicitation for new and competing renewal awards, depending on the availability of funds, it is expected that a subsequent competition among funded CRROHD centers will be held. The total project period for an application submitted in response to this RFA may not exceed seven years and it is anticipated that the subsequent competition will be for funding for a similar period. The earliest possible date for funding is August 2001. FUNDS AVAILABLE Up to five awards will be made if a sufficient number of highly meritorious applications are received and sufficient funds are available. Additional centers may be funded depending on the availability of funds and highly meritorious applications. Each award may not exceed $1.5 million total costs (i.e., direct plus indirect costs including those indirect costs associated with consortia and/or contracts) for research projects, pilot projects and cores in the first year. Increases in costs for subsequent years may not exceed three percent. All applicants must include costs associated with annual meetings in Bethesda of center directors and their key scientific personnel. In addition, centers that propose a prospective, randomized clinical trial must include funds for annual meetings of an independent Data and Safety Monitoring Board (DSMB) to provide oversight and review of patient safety and progress of the trial. Information about the structure and function of the DSMB is available from NIDCR staff listed under INQUIRIES or from the NIDCR home page (http://www.nidcr.nih.gov). It is strongly urged that additional funds be sought from other federal agencies as well as from institutional, corporate and foundation sources to augment support from the NIDCR. Award of grants pursuant to this RFA is contingent upon the availability of funds. RESEARCH OBJECTIVES Background Dental and craniofacial diseases and disorders are among the most common health problems affecting the people of the United States. The burden imposed by a variety of dental and craniofacial diseases and disorders range from birth defects such as cleft lip and palate, which occurs in every 1 in 525 to 714 live births, to injuries to the head and face, resulting in nearly 20 million emergency room visits per year, to devastating head and neck cancers, accounting for 8000 deaths and over 30,000 new cases per year. The treatment of over 1.2 million cancer patients each year can lead to complications such as painful mouth ulcers, mucositis, rampant dental caries, fungal infections, impaired taste and loss of function of the salivary glands. Oral infections still remain common in our populations. Dental caries is experienced by 45% of elementary aged school children and 94% of adults have experienced this infection at some point in life. Periodontal infections occur in 90% of individuals older than 13 years and may be associated with other systemic diseases or conditions such as diabetes, cardiovascular disease, respiratory infections, and pre-term/low birth weight babies. Orofacial pain is likely to have been experienced by over 20% of adults in the past six months, is a major component of temporomandibular joint diseases (TMD) for at least 6% of adults, and is a major component of Bell"s palsy, trigeminal neuralgia and fibromyalgia. Salivary gland dysfunction in the form of Sjogren"s syndrome affects between 1 and 4 million Americans while over 30,000 individuals who have cystic fibrosis are also at higher risk for concomitant salivary gland dysfunction. Further, over 500 prescription drugs have xerostomic (dry mouth) side effects, increasing the risk for both bacterial and fungal oral infections as well as other oral conditions. Oral candidiasis is commonly found in HIV-infected patients. Many of these craniofacial, oral and dental diseases and disorders have a disproportionately higher burden on particular population subgroups. Addressing disparities in craniofacial, oral and dental health among the diverse populations of the United States continues to be a major focus of the research supported by the NIDCR. Strategic Initiative I (Research Opportunities) of the strategic plan, "SHAPING THE FUTURE" (http://www.nidcr.nih.gov), focuses on, among other areas, the importance of oral health promotion and disease prevention, behavioral research, and epidemiological research as areas of importance to the Institute. Strategic Initiative III (Health Promotion) calls for research that addresses the health needs of all segments of the United States population. Furthermore, Strategic Initiative II (Research Capacity) of the current NIDCR strategic plan states that, in developing the human and technological resources needed to realize the full potential of scientific opportunities, one of the primary objectives of the Institute is to facilitate the participation of women, ethnic and racial minorities, and individuals with disabilities in research. As such, the current initiative continues a focus on the development of collaborations that can strengthen the capacity of institutions to plan and conduct scientifically meritorious research and to engage in appropriate research training and career development of individuals associated with these institutions. It is still evident that in the United States the burden of disease falls disproportionately among racial and ethnic minorities, individuals from lower socioeconomic classes, women and children. Nearly 50 million Americans suffer from disproportionately high incidence and prevalence of a wide range of diseases and disorders. Among these are inherited and acquired birth defects, craniofacial/oral trauma, infectious diseases, severe malocclusion and orthognathic conditions, oral complications of systemic diseases, oral and pharyngeal cancer, temporomandibular diseases, chronic facial pain and other diseases and conditions of the oral and craniofacial complex and the rest of the body. A recent report issued by the Department of Health and Human Services titled "Racial and Ethnic Disparities in Health: Response to the President"s Initiative on Race" recognizes the need for new knowledge about the determinants of disease and effective interventions for prevention and treatment to eliminate health disparities. The report targets six goals aimed at addressing specific health disparities including infant mortality, cancer, cardiovascular disease, diabetes, HIV/AIDS, and immunization. As documented in the publication, "Women of Color Health Data Book," women and men of color are disproportionately represented among the nearly 41 million Americans without health insurance and it is known that there is uneven access to health care and heath care resources among the diverse populations of the United States (NIH Publication 98-4247, 1998, p.68). Similar documentation, particularly that pertaining to the health of women and children, is available through the home page for the Public Health Service Office of Women"s Health (http://www.4women.gov/owh/index.htm). While it is estimated that 14% of all whites did not have coverage in 1995, the same was true for 21% of African Americans and 33% of Hispanics (NIH Publication 98-4247, 1998, p.68). These percentages increase for all groups for individuals of lower socioeconomic status. Furthermore, African Americans (20%) than whites (13%) reported that they used hospital emergency departments as their source of primary health care. Conversely, 58% percent of whites and 48% percent of African Americans make their usual contact with physicians in a non-hospital setting such as the typical office (NIH Publication 98-4247, 1998, p. 70). The impact of these differences on health is profound and may account for many of the increased risk factors for disease among underserved populations. For example, it has been reported (NIH Publication 98-4247, p. 73-76) that white women exhibit among the highest incidence of all forms of cancer (i.e., 346/100,000) yet mortality rates are lower for them (i.e., 140/100,000) than for Alaskan Natives (i.e., 179/100,000), Native Hawaiians (i.e., 168/100,000), and African Americans (i.e., 168/100,000). A similar picture emerges when comparisons are made for specific forms of cancer, including breast and cervical cancer. It has been speculated that this pattern can be accounted for by several interrelated factors including later detection of disease, unequal access to health care resulting from lower access to health insurance, geographically more remote health care facilities for women of color than white women, and problems associated with the reliability of surveys on low SES individuals (e.g., underreporting, misidentification of race or ethnicity, misidentification of causes of mortality). Other factors involved in the causes of health disparities are varied and complex (Haynes & Smedley, 1999, Williams & Collins, 1995). Traditional variables have included race, ethnicity or culture, socioeconomic status (SES), gender/sex and age. Yet it appears that none of these alone can account for all of the documented differences. Williams and Collins (1995) note that even socioeconomic status as a measure of class leaves much of the variability in health status unexplained. They note that research on the determinants of health indicates that stress in family home and work environments, health practices, social support systems, access to health care, and attitudes toward health are all important determinants of health status. Another example, highlighted in a chapter outlining a research agenda on women"s oral health in a publication from the Office of Research on Women"s Health, NIH points to the potential role of gender/sex in health disparities and the need for much research involving women (Redford, Jeffcoat & Silverton, 1999). In many instances a woman is not only the major caregiver of children but she is also the source of much health information for others in the family group. This coupled with the fact that there is still much to be learned about factors influencing women"s oral health, points to a need for research involving this very important segment of our population. As noted by Anderson (1998) discovering the interrelationships among the multitude of variables that affect health and disease, their relationship(s) to more traditional variables, and, ultimately, the relationship between all of these factors and the underlying biological and physiological processes involved in health and disease is critical in our understanding of disease and hence for understanding the bases for health disparities as well as providing a pathway to preventing and reducing them. Research from within the field of oral health illustrates some of the complexities that are emerging from research on health disparities. Race and ethnicity appear to influence health beliefs and perceptions of health. Beliefs and perceptions, in turn, can determine when or if an individual seeks treatment (Kuthy, Odom, Salsberry, Nickel, & Polivka, 1998, Kwan, Williams & Duggal, 1996, Gift, Atchison & Drury, 1998). Perceptions of oral health, particularly of those conditions which an individual believes to be "normal", can be influenced by age, race, ethnicity, education, general health, and utilization of the health care system (Atchison & Gift, 1997). While it is known that the lack of health care providers from with a given racial/ethnic group influences health status in persons from within those groups obtaining timely and appropriate health care (Grumbach, Coffman, Young, Vranizan & Blick, 1998) little is known about similar influences on craniofacial, oral and dental diseases and disorders. Similarly, while it is known functional health literacy influences health status among the elderly (Gazmararian, Baker, Williams, Parker, Scott, Green, Fehrenbach, Ren, & Koplan, 1999), the low-income elderly (Weiss, Reed & Kligman, 1995) as well as individuals of various racial/ethnic groups (Williams, Parker, Baker, Parikh, Pitkin, Coates & Nurss, 1995) little is known about the influence of these factors on craniofacial, oral and dental diseases and disorders. According to the draft version of "Healthy People 2010," the level of untreated dental caries among racial and ethnic minority groups is greater than the national average, smaller proportions of minority and poor children have dental sealants, African Americans have a poorer five-year survival rate for oral and pharyngeal cancer than whites (31% vs. 55%), and almost nine percent of low SES adults have lost all their teeth compared with five percent in the total adult population. Forty-two percent of the poor elderly were edentulous in 1993 compared with 36% of all persons 65 years and older. The proportion of the U.S. population that makes at least an annual dental visit as well as the average number of dental visits made per year vary significantly by age, race, and family income. The proportion of the population with an annual dental visit is highest among children between 5 and 17 years and lowest among children between 2 and 4 years. About 57% of the total U.S. population over 2 years report a dental visit in the past year, but fewer than one-half of those over 65 years have made such a visit. Only 41% of those with annual family incomes below $10,000 report a dental visit in the past year compared with 73% with family incomes above $35,000. As noted in the draft version of "Healthy People 2010," dental insurance coverage is a strong predictor of the use of dental services. Because dental insurance is typically employment-based, persons who do not work or who work only part time or who are self-employed are less likely to be insured and hence less likely to use dental services than full-time employees. The National Association of Dental Plans estimates that 45% of the 1995 U.S. population had dental insurance and Medicaid coverage for adults varies from state to state. Lower proportions of low SES children and members of racial and ethnic minority groups have private dental insurance than the national average. Although public sector programs such as Medicaid, and more recently Children"s Health Insurance Program (CHIP), hold great promise for improving the oral health of many low income and minority children, access barriers may temper that potential. Low SES children make 37% fewer visits of dental offices than do those from higher SES groups and children from families below 200 percent of the Federal Poverty Level have substantially more unmet dental treatment needs than children from families with higher income levels (Vargas, et. al, 1998). Similarly, lower proportions of members of racial and ethnic minorities and low SES adults than the general population have made dental visits in the past year. Visits to dentists by elderly African Americans (22%) and all poor elderly (26%) during the past year are approximately one- half of the national average for the elderly. Only 15% of the elderly have any private dental insurance and Medicare does not provide reimbursement for routine dental services. The relatively poor health status of underserved populations may also reflect the lack of research on these individuals, particularly with respect to craniofacial, oral and dental diseases and disorders. This may, in turn, be a reflection of the relative scarcity of culturally and economically sensitive, well-trained scientists engaging in craniofacial, oral and dental health research. Limited opportunities for individuals from various racial/ethnic groups to receive training and mentoring in research activities not only because of a lack of research resources at their home institutions but also because of a lack of opportunities to engage in research play a large role in the shortage of culturally sensitive and competent scientists. While the NIDCR continues to encourage the participation of minority scientists in health research through various training programs as well as through the Research Supplements for Underrepresented Minorities initiative, additional opportunities are also needed. Thus, in addition to the principal aim of this initiative to support research to reduce health disparities, a complementary aim is to enhance the future funding opportunities for scientists at non- research intensive institutions by pairing them, through collaborative affiliations, with individuals at research intensive institutions. It is anticipated that accomplishment of this aim will not only enhance the research careers of individuals underrepresented in the scientific workforce but it will also attract qualified underrepresented undergraduate and graduate students to careers related to reducing health disparities, especially those related to craniofacial, oral and dental diseases and disorders. Center Characteristics The Centers for Research to Reduce Oral Health Disparities are viewed as a national and all encompassing resource. Even though funds provided through this RFA are restricted to the support of research activities, it is expected that each application will include specific plans for developing training and career development opportunities. Each center is required to involve a partnership with one or more minority institutions (e.g., Historically Black Colleges and Universities, Hispanic serving institutions, Tribal Colleges and Universities). The applicant may be either the minority or non-minority institution. An application that does not include such a collaboration will not be considered for funding and be returned to the applicant unreviewed. For the purposes of this RFA a minority institution is defined as: (a) providing education or training for individuals from underrepresented groups within the craniofacial, oral and dental scientific workforce (i.e., an educational, health care, academic health center, medical school, dental school, nursing school, public health school or research institution whose student enrollment and faculty consists of 50 percent or more individuals from underrepresented groups such as American Indians and Alaskan Natives, African Americans, Hispanics, and Asian Americans/Pacific Islanders), and/or (b) serving large underserved populations (i.e., an educational, health care, academic health center, medical school, dental school, nursing school, public health school or research institution whose patient population consists of 50 percent or more of individuals from groups traditionally considered to be under served with respect to their craniofacial, oral and dental health needs). Each center will represent a consortium consisting of two or more institutions as well as collaborations between departments, divisions and schools within a single institution. Examples of components of research and institutional consortia include: o inter-institutional networks such as partnerships among colleges and universities, State and Local health financing agencies, State departments of education, HRSA Community/Migrant Health Centers, CDC Prevention Research Centers, tribal urban and direct Indian Health Service clinics and hospitals, and academic health centers, o inter-disciplinary health professions networks such as partnerships among dental, medical, nursing, pharmacy, and public health colleges and schools, and o multi-disciplinary networks such as partnerships among basic and social science programs and clinical and epidemiologic science programs. The grantee institution must be an educational, academic health center, medical school, dental school, nursing school, and public health school or research institution. Institutions comprising the consortia should be selected to facilitate the attainment of the scientific objectives of the center and may include community health centers, State and Local health and health financing agencies (e.g., CHIP, Medicaid), HMOs or PPOs, nursing homes or other government funded organizations (e.g., HRSA Community/Migrant Health Centers, CDC Prevention Research Centers, tribal urban and direct Indian Health Service clinics and hospitals). The specific combination of the above elements included in the design of an individual center will be determined by the scientific aims of that center and the resources that the participating partners have to offer in addressing these aims. Each application must justify the specific pattern of collaboration in light of the scientific goals of the center. Center Administration. A director, affiliated with the applicant institution, and a co-director(s), affiliated with the principal collaborating institution(s), will be responsible for the scientific and administrative leadership of the center. An administrative advisory committee of senior staff from the principal participating institutions will assist the director. Membership on this committee may be supplemented as needed by individuals from outside the participating institutions. The role of this committee is to provide administrative advice to the director by assisting in the preparation of the application as well as advising the director on scientific and related issues including faculty development activities. In addition, an independent scientific advisory committee consisting of consultants with appropriate research experience and accomplishments, but who are not associated with the participating institutions, will conduct an annual review of the: (1) broad goals and accomplishments of the center including outreach, mentoring, career development and training activities, (2) asses interim progress of all scientific projects and their relevance to the broad objectives of this initiative, and (3) aid in the review of pilot projects proposed after initiation of the grant. NIDCR staff will serve as ex officio members of the steering committee. Also, a Data and Safety Monitoring Board (DSMB), formed in accordance with NIDCR guidelines, is required for any prospective randomized clinical trials research included within a center. Applicants anticipating including a clinical trial as part of the center should obtain a copy of the guidelines from the NIDCR staff listed under "INQUIRIES." Research Projects. The center will consist of a series of related research projects and cores which, overall, focus on reducing craniofacial, oral and dental health disparities. At least four (4) of them will be R01-type research projects. Each project will involve participation by co- investigators from the collaborating institutions. Applicants must develop a central theme around which the research projects are organized. In being consistent with the intent of this initiative, the theme should address basic, translational and clinical, patient-oriented, health services, and community- based research issues relating to health disparities (e.g., molecular epidemiological studies, health promotion research, clinical trials). In addition, each center is strongly encouraged to include, under its administrative umbrella, related but already funded research as well as research training and career development activities related to the specific aims of the research. Reference to and descriptions of these grants along with the specific scientific aims to which they apply should be contained in the application. Pilot Projects. Each center may, in addition to regular research projects, include short-term pilot projects. The purpose of these projects is to support pilot studies that can lead to regular research projects funded as part of the center grant or as freestanding grants. Each pilot project may not be funded for more than $15,000 and for no longer than one year. No more than a total of five such projects may be supported in any single grant year. Administration of the projects should be within an administrative core as part of the center development activities (see below). Applicants are limited to a one-page description of each of the initially proposed pilot project. The major focus of each description should be the overall purpose, specific aims and general approach of the proposed pilot research. Applicants also must provide a detailed description of the process involved in selecting pilot projects included in the center application as well as the process that will be used in evaluating their outcomes and in selecting a new set of projects. Core Facilities. Core resources supporting center development activities, outreach and educational activities, administrative services, unique clinical facilities, biostatistical and computer services and shared equipment should be included. The level of support for core resources must be commensurate with the level of research proposed and funded. The center administrative core must include support of meetings or other activities to explore new and expanded collaborative research, research training, and career development opportunities. Travel for the director, co-director and developing scientists to an annual meeting of center directors in Bethesda must be budgeted in the administrative core as should support of travel for annual meetings of a Data and Safety Monitoring Board for those centers that involve prospective randomized clinical trials. Equipment and Facilities. No funding will be provided for major pieces of equipment or renovation of existing facilities or building of new facilities. Research and Training Networks Receipt of a CRROHD carries with it the expectation that the center will provide the impetus and core for research and training networks on health disparities. These networks can take on many forms and serve a variety of purposes. The purpose of the networks is to leverage the resources available through the center, and in so doing to, facilitate research and research training by linking these resources with other sites around the country where the necessary expertise, facilities, capabilities and research opportunities may be readily available. Another function of the networks is to enhance the opportunities by center staff for access to populations and communities that may not be available locally. One approach in forming a network could be the establishment of collaborations among the centers that are funded through this RFA. In facilitating this activity, NIDCR staff will organize annual scientific meetings of center directors and staff in Bethesda. Additional collaborations between the CRROHD centers and other NIH funded grantees (e.g., NIDCR"s Comprehensive Oral Health Research Centers Of Discovery, NIDCR"s Oral Cancer Centers, NIDCR"s Clinical Core Centers) as well as with other federal agencies (e.g., HRSA Community/Migrant Health Centers, CDC Prevention Research Centers, tribal urban and direct Indian Health Service clinics and hospitals) are also encouraged as a way of establishing networks. Applicants should provide detailed plans and milestones for the formation of such networks including a means for assessing progress and outcomes. Research Career Development and Training Opportunities While formal research training cannot be supported by this research grant mechanism, it is understood that participation in research supported by this initiative can have a significant impact on the career development of underrepresented minorities in the scientific workforce. Successful applicants are strongly encouraged to use existing research training and/or career development programs to encourage qualified and interested individuals to participate in the research funded under this RFA. Applications from institutions that already have existing research training or career development programs such as an institutional CLINICAL RESEARCH CURRICULUM AWARD (K30) must include detailed plans for the use of these programs in enhancing the research training and/or career development activities of faculty participating in the research activities of the center. Applicant institutions that do not have existing research training or career development programs are expected to apply for parallel support for these activities. In addition to the more traditional mechanisms in support of training (i.e., National Research Service Award (NRSA) program, which can support Individual fellowships (F32), institutional training (T32), and short- term training (T35) awards) and career development (i.e., K23 Mentored Patient-Oriented Research Career Development Award, K24 Mid-Career Investigator Award in Patient-Oriented Research), the Research Centers at Minority Institutions (RCMI) program of the National Center for Research Resources may provide funds for faculty development activities for eligible faculty members from RCMI eligible institutions. Plans for the development of these applications must be included in the center application. Successful applicants are eligible to apply for funding to support under the Research Supplements For Underrepresented Minorities Program as well as the Research Supplements For Individuals With Disabilities Program. A maximum of one such supplement per project may be requested following an award. Information about these programs is available through the NIH Home Page (http://www.nih.gov/) or the NIDCR Home Page (http://www.nidcr.nih.gov/) or by contacting NIDCR staff listed under "INQUIRIES." Evaluation of Impact Congruent with the objectives of "Healthy People 2010" and as noted earlier, the purpose of this RFA is to support research that will ultimately reduce health disparities. Thus applicants are asked to develop and outline an evaluation process, including benchmarks, milestones and health status related outcomes, that will allow an assessment of progress toward reducing the health disparity(ies) through the research conducted by the center. Suggested measures include level or status of craniofacial, oral or dental disease, including their potential influences on status of general health, in a sample, community, or population being studied. Other measures of success might include extent of the adoption of preventive health practices within a group. Scientific and Research Opportunities While the overall intent of this initiative is to support research that leads to a reduction in the craniofacial, oral and dental health disparities in children (i.e., individuals from birth to 21 years), the scientific and research opportunities for a given center can be broad. For example, an individual center may focus on research aimed at understanding the relationships between maternal oral health and infant morbidity and mortality while another may focus only on that which addresses an oral disease of childhood (e.g., dental caries, juvenile periodontitis). Still other centers might propose systematic studies and comparisons between populations and subpopulations of ethnic and culturally distinct individuals while others might propose studies aimed at uncovering the interrelationships between socioeconomic/sociodemographic variables and biological underpinnings of craniofacial, oral and dental diseases. The thread common to all of the centers should be the development of knowledge that will lead to an understanding of the biological, behavioral, anthropological, sociological, and economic causes of oral health disparities in the United States as well as to the design and testing of interventions that will lead to the reduction and prevention of these health disparities. They should lead to the design of interventions that rely on and build upon the cultural competencies involved in health of members of various groups. Multi- and inter-disciplinary research extending from the workings of the cell to that of the community within which the individual lives is necessary to reach a level of understanding that will help reduce disparities in disease among the various groups. Each center should be organized around a single scientific theme. Proposed studies should address the theme from a multi-disciplinary perspective and in a way that will help lead to an understanding of health and disease disparities as they relate to congenital craniofacial diseases and disorders, orofacial injury, dental caries, periodontal disease, head and neck cancer, autoimmune diseases, salivary dysfunction, chronic pain conditions and response to pain, temporomandibular joint diseases and other chronic disabling diseases of the craniofacial-oral-dental complex. The theme can address a specific health issue or set of issues involving craniofacial, oral or dental diseases and disorders. It can be directed at an assessment of any one or a combination of biological, behavioral, psychological, sociological, economic, educational, cultural or other factors that contribute to a particular health disparity or to health disparities in general. It can focus on either or both prevention and treatment and it can be individual-, sample-, community-, or population-based. And, finally, the theme can represent a unique combination of these possibilities. In developing the theme, applicants may want to consider the following topics. These are not listed in priority order nor are they comprehensive or restrictive. The final selection of a theme is the choice of the applicant and may include any of the following: o incidence and prevalence of craniofacial, oral and dental diseases in underserved populations and subpopulations including analyses of these data for women, o the relative role of biological factors, physical environment, socioeconomic factors, lifestyle and culture, ethnicity, and race in oral health status, o the role of caregivers (e.g., persons and institutions) in the craniofacial, oral and dental health or disease in children including the relationship between the oral/systemic health of caregivers (e.g., siblings, parents, grandparents, baby sitters, aunts/uncles, etc) and oral health of the child, o impact of health care services, health care financing and insurance plan design, reimbursement and organization (e.g., managed care) on the availability of, access to, and utilization of high quality oral health care services, o studies involving at the design and testing of effective health promotion interventions involving community-based health education and information dissemination activities regarding nutrition, reduction of tobacco use, maternal, infant and child health care, head and neck cancer, diabetes, substance abuse, degenerative bone diseases, and access to quality health care services, o knowledge and use of health care practices and their influence on oral, dental and systemic health, o oral manifestations of AIDS/HIV and other viral, bacterial or fungal infectious diseases, o studies of the underlying genetic, nutritional, behavioral and environmental factors involved in cleft-lip and palate and other craniofacial diseases in U.S.-born and immigrant populations, o studies to establish the relationship between oral diseases (e.g., oral infections) and diseases of other organ systems (e.g., diabetes, cardiovascular disease, pre-term low birth weight babies) in underserved populations or populations at higher risk for oral and/or systemic disease as well as studies to design and test interventions aimed at reducing the disease burden in these groups, o studies of the molecular events involved in tissue growth and wound healing in underserved populations particularly following surgery for injury or for soft tissue disease (e.g., oral/pharyngeal cancer) or injury, o studies designed to investigate factors contributing to the excess morbidity and mortality associated with craniofacial and oral diseases (e.g., cancer and precancer, autoimmune diseases) in underserved populations, and o studies of dietary and nutritional factors in the prevention and treatment of craniofacial, oral and dental diseases in underserved populations. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 NIDCR staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to the program staff listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. INFORMATIONAL CONFERENCES A series of regional informational conferences addressing the scientific and administrative issues associated with this initiative will be held throughout the United States. Planned locations include Boston, Atlanta, Chicago, Dallas and San Francisco. Logistic information, including dates, times and locations within each of the aforementioned cities, will be posted on the NIDCR home page (http://www.nidcr.nih.gov/), will be announced through other media and may be obtained from program staff listed under INQUIRIES. APPLICATION PROCEDURES Prospective applicants are encouraged to communicate with NIDCR Division of Extramural Research scientific program and grants management staff as early as possible in the planning stage of application. The research grant application form PHS 398 (rev.4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Research Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, Maryland 20892-7910, telephone (301) 710-0267, Email: [email protected] or from the internet website at: http://grants.nih.gov/grants/forms.htm When using the PHS 398 application form to respond to an RFA, applicants must affix the RFA label available in the application kit to the bottom of the face page. 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 in item 2a of the face page of the application form and the YES box checked. The RFA label and line 2 of the application should both indicate the RFA number. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. The instructions accompanying form PHS 398 must be followed as completely as possible, but some modification will be necessary. For example, a new Table of Contents must be prepared giving page numbers for all items in the application. Pagination must be consecutive throughout the application. Each subproject must be identified by number and investigator. Separate detailed budgets for each year for the entire center, core resources, and subprojects and pilot projects should be prepared. A consolidated budget for the center for all years of support should be included (use pages DD-EE, Form PHS 398). Direct and indirect cost estimates must be provided. Funds may be requested for professional, technical, and administrative personnel, core resources, equipment, supplies, consultant services, travel, publication costs, and patient costs directly related to the research. Detailed justification of all budget requests will be required and commitment of collaborating institutions to the center should be fully documented. A summary of financial support from non-NIDCR sources for studies that will complement and expand the program supported by the NIDCR must be provided. It is important to explain how the support of these studies would further the goals of the center and make it more cost effective. Under Research Plan, the goals of the center must be described and background and significance of the topics being addressed discussed. Also, each research project, core and the faculty development activities must be fully explained in light of how they contribute to achieving these goals. The organizational and administrative structure, the responsibilities of the director and co- director(s), individual investigators and the proposed mechanisms for monitoring scientific progress must be described in detail. Each research project must be presented as if it were a research grant application (R01). However, additional face pages are NOT necessary for each research project. There should be only one face page per center application. Instructions for pages 19-24 of form PHS 398 should be followed. For the Research Plan, a 25-page limitation will apply to each research project. The length of each core unit description may not exceed 25 pages. A page BB (Abstract form PHS-398) should be completed for the core resources, each subproject, pilot project, and for the entire application. The training/career development component of the application, including the scientific proposal, the formal and informal course of study and the seminars, journal club, plans to submit parallel applications for or to fold in existing training/career development grants and other similar activities should be submitted as an appendix to the application and should not exceed 10 pages. 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 also be sent to: Dr. H. George Hausch Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-38D MSC 6402 Bethesda, MD 20892-6402 Applications must be received by November 15, 2000. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt applications will be reviewed by NIH staff for completeness and responsiveness. Applications that are incomplete, non-responsive to this RFA, or exceed the first year budget limit of $1.5 million in total costs (i.e., direct plus indirect including any indirect costs associated with contracts or consortia) 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 NIDCR in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications receive a written critique and 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, assigned a priority score, and receive a second level review by the National Advisory Dental and Craniofacial Research Council. Funding from other NIH sources may require secondary review by their national advisory bodies. Review Criteria Listed below are the review criteria to be used in the evaluation of the applications, these criteria will be applied to competing continuations by evaluating progress and to new applications by evaluating preliminary work and plans for implementation of the new program. Center (as a whole): a. Qualifications of center director, co-director(s) and key staff to provide scientific and mentoring leadership. b. Integration between and balance among research projects, pilot projects and cores and their relevance to the goals of the RFA to conduct research on health disparities of children and their caregivers. c. The potential of the center to become or maintain itself as a regional and national resource, including capacity to provide quality research training and mentoring, opportunities for independent research career development, and plans for research information dissemination and education activities. Included here will be an assessment of feasibility of plans for the development of (1) research networks in support of the scientific aims of the center and (2) parallel applications for research career development and training awards. d. Appropriateness of the collaborations with respect to the scientific aims of the center including the appropriate use of collaborations to access appropriate populations for study and appropriate multi-disciplinary scientific expertise from inter- and intra-institutional collaborations. e. Unique scientific contributions of the center, including significance, innovation, scientific productivity, and recognition through publications, new research grants, honors and awards. f. Multidisciplinary scope of the center, its cohesiveness, coordination, and interrelation, and the synergistic potential among the center core and projects. g. Evidence that the administrative structure of the center and collaboration between institutions has functioned well in the development of the application. h. Evidence of institutional support as well as support or potential support for parallel activities (e.g., research training, related research projects). i. The degree to which the research, training, career development and educational activities will enhance collaborative and/or interdisciplinary research within the center and the research community as a whole. j. In addition to all of the foregoing criteria, competitive renewal applications funded under the RRCMOH program will be assessed for the impact of the Center during the previous grant period on expanding the knowledge base concerning health disparities among U.S. populations, on providing research opportunities for minority scientists by encouraging their participation in craniofacial, oral and dental research, and on developing and strengthening the biomedical and behavioral oral health research capacity. k. Adequacy of the evaluation plan to assess the extent to which research conducted by the center will contribute to the reduction of health disparities among children and their caregivers. Research Projects (for each project): a. Significance: Does the project address an important problem? If aims of the project are accomplished, how will scientific knowledge be advanced? What will the effects of the project be on our knowledge about the causes of and remedies for health disparities? b. Approach: Are the conceptual framework, design, methods and analyses adequately developed, well integrated and appropriate to the aims of the project? Does the investigator acknowledge potential problems and consider alternative approaches? c. Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? d. Investigator: Is the investigator appropriately trained and well suited to carry out the work? Is the work proposed appropriate to the experience level of the principle investigator and other researchers (if any) associated with the project? e. Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed study take advantage of unique features of the scientific environment or maximize on the collaborative arrangement among the components of the center? Pilot Projects (as a whole): a. The extent to which the group of pilot projects as a whole is integrated into and will contribute to the scientific aims of the center. b. Process for developing, selecting and monitoring progress of projects included in the application as well as those that will be included in the future. Core Facilities: a. For each core, evidence that the core will provide the necessary support required for the successful completion of projects and pilot projects. In addition, for competing continuation applications, evidence that this has occurred. b. Qualifications of staff for each core. c. Quality and availability of core resources. d. Feasibility of the plan for recruitment of individuals from underserved populations. In competing continuation applications, progress that has been made in increasing participation of diverse populations in the center activities. AWARD CRITERIA The earliest anticipated date of award is August, 2001. Applicants should be aware that, in addition to scientific merit, program priorities and program balance, the total cost of the proposed project and the availability of funds will be considered by the NIDCR staff and the National Advisory Dental and Craniofacial Research Council in making funding recommendations. The NIDCR appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIDCR. INQUIRIES Written, email and telephone inquiries concerning this RFA are encouraged, particularly early in the application development process. The opportunity to clarify any issues or questions from potential applicants is welcome. All inquiries should be directed to NIDCR staff listed below who may refer questions to individuals from collaborating organizations and/or institutes. Direct inquiries regarding scientific programmatic issues to: Dr. Norman S. Braveman Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-24A, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8318 Email: [email protected] Inquiries regarding career development and NRSA training opportunities may be directed to: Dr. James A. Lipton Assistant Director for Training and Career Development Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-18J, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2618 FAX: (301) 480-8318 Email: [email protected] Direct inquiries regarding grants management issues to: Mr. Martin R. Rubinstein Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44A, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 Email: [email protected] SCHEDULE Letter of Intent Receipt Date: July 17, 2000 Application Receipt Date: November 15, 2000 Scientific Review Date: January, 2001 Advisory Council Date: May, 2001 Earliest Award Date: August, 2001 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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. REFERENCES Anderson, N. B. Levels of analysis in health science: A framework for integrating sociobehavioral and biomedical research. Annals of the New York Academy of Sciences, 1998, 840, 563-576. Atchison, K. A. & Gift, H. C. Perceived oral health in a diverse sample. Advances in Dental Research, 1997, 11: 272-280. Gazmararian, J.A., Baker, D.W., Williams, M.V., Parker, R. M., Scott, T. L., Green, D. C., Fehrenbach, S. N., Ren, J. & Koplan, J.P. Health literacy among Medicare enrollees in a managed care organization. Journal of the American Medical Association, 1999, 281, 545-551. Gift, H. C., Atchison, K. A., & Drury, T. F. Perceptions of the natural dentition in the context of multiple variables. Journal of Dental Research, 1998, 77: 1529-1538. Grumbach, K., Coffman, J. M., Young, J. Q, Vranizan, K., & Blick, N. Physician supply and medical education in California: A comparison with national trends. Western Journal of Medicine, 1998, 168, 412-421. Haynes, M.A. & Smedley, B. D. (Eds.) The Unequal Burden of Cancer: An Assessment of NIH Programs for Ethnic Minorities and the Medically Underserved. Institute of Medicine. National Academy Press. Washington, DC, 1999.I Kuthy, R.A., Odom, J.G., Salsberry, P.J., Nickel, J. L., & Polivka, B.J. Dental utilization by low-income mothers. Journal of Public Health Dentistry, 1998, 58: 44-50. Kwan, S. L., Williams, S.A., & Duggal, M. S. An assessment of the appropriateness of dental health education materials for ethnic minorities. International Dental Journal, 1996, 46:277-285. NIH Publication 98-4247. Women of Color Health Data Book. Office of Research On Women"s Health, Office of the Director, National Institutes of Health, 1998. Redford, M., Jeffcoat, M. & Silverton, S. Oral Health. In Agenda for Research on Women"s Health for the 21st Century: A Report of the Task Force on the NIH Women"s Health Research Agenda for the 21st Century, Volume 2. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NIH Publication No. 99-4386-1999. Vargas, C.M., Crall, J.J., & Schneider, D.A. Sociodemographic distribution of pediatric dental caries: NHANES III, 1998-1994. Journal of the American Dental Association, 1998, 129,1229-1238. Weiss, B. D., Reed, R. L., & Kligman, E. W. Literary skills and communication methods of low-income older persons. Patient Education and Counseling, 1995, 25, 109-119. Williams, D. R. & Collins, C. US Socioeconomic and Racial Differences in Health: Patterns and Explanations. Annual Review of Sociology, 1995, 21:349- 386. Williams, M.V., Parker, R. M., Baker, D. W., Parikh, N. S., Pitkin, K., Coates, W. C., & Nurss, J. R. Inadequate functional health literacy among patients at two public hospitals. Journal of the American Medical Association, 1995, 274, 1677-1682.

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