RFA-DE-02-005: PLANNING GRANTS FOR RESEARCH TO PREVENT OR REDUCE ORAL HEALTH DISPARITIES

Department of Health
and Human Services (HHS)

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PLANNING GRANTS FOR RESEARCH TO PREVENT OR REDUCE ORAL HEALTH DISPARITIES Release Date: January 11, 2002 RFA: RFA-DE-02-005 National Institute of Dental and Craniofacial Research (http://www.nidcr.nih.gov) National Center on Minority Health and Health Disparities (http://www.ncmhd.nih.gov) Office of Research on Women's Health (http://www4.od.nih.gov/orwh) Letter of Intent Receipt Date: March 21, 2002 Application Receipt Date: April 18, 2002 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Dental and Craniofacial Research (NIDCR), the National Center on Minority Health and Health Disparities (NCMHD), and the Office of Research on Women's Health (ORWH) invite applications for planning grants (R21) to develop the research collaborations, plans and infrastructure necessary to conduct scientifically meritorious research on determinants of oral health disparities and prevention or reduction of oral health disparities in selected populations currently under-represented in NIDCR's grant portfolio. Research topics and oral conditions, and populations relevant to eliminating oral health disparities are discussed in NIDCR's "A Plan to Eliminate Craniofacial, Oral and Dental Health Disparities" http://www.nidcr.nih.gov/research/health_disp.asp. Potential applicants should refer to this document for a listing and explanation of research topics and populations of interest to the Institute. In particular low- income rural populations, special needs populations including those with neurodevelopmental disorders, and all race/ethnic populations are of interest. Race/ethnic study populations underrepresented in the NIDCR research portfolio include Hispanic (Central American, Cuban-American, Puerto Rican, and others), American Indian or Alaskan Native, and Asian or Pacific Islander populations. Much remains to be learned about the broad array of factors which by themselves or in combination contribute to disparities in the oral, dental, and craniofacial diseases, disorders and conditions amongst these populations, how oral health disparities impact upon quality of life, and what interventions improve quality of life and prevent or reduce the inequalities across the lifespan. The purpose of the planning grants will be to support the organization of research teams and the development of elements essential for conducting successful research to prevent, reduce and ultimately eliminate a specific oral health disparity (or oral health disparities) within the selected population. The planning grants are intended to provide support for the development of a refined research question (s), specific study design, organizational plan, detailed protocol including details regarding access to the population, and budget. Applications must address the specific health disparity (or disparities) that the research plan will address, and the population(s) in which the study(s) will be conducted. In addition, investigators must indicate collaborators involved in the development of the research plan, indicate how the planning process will facilitate collaboration and the scientific merit of the research plans being developed, and specify what facilities and administrative procedures will be used. Investigators are encouraged to develop plans for research that would utilize innovative approaches and that show some potential to become sustainable in the population once external research funding is removed. If applicants are at the stage of testing research methods and instruments or the collection of preliminary data related to the prevention and reduction of oral health disparities, they are asked to refer to a pilot grant RFA that is being released simultaneously. If any findings from pilot studies are already available, they should be discussed in relationship to the planning process proposed. The purpose of the planning grant is to develop plans and collaborative arrangements that will provide a sound foundation for conducting scientifically meritorious, single or multi-site studies to prevent or reduce specific oral health disparities. The primary emphasis of this RFA is on planning so that applicants can be prepared to initiate research on the topic and with the population identified. It is anticipated that after the planning is completed awardees would submit applications to conduct investigator initiated (R01 or IRPG) research. Awards under this RFA are not intended to serve as an alternative mechanism of support for projects not receiving funding as competitive continuation applications. The current RFA and two other RFAs being issued concurrently ("Pilot Grants to Prevent or Reduce Oral Health Disparities" (DE-02-004) and "Research Infrastructure and Capacity Building for Minority Institutions to Reduce Oral Health Disparities" (DE-02-003) reflect a strong commitment on the part of the National Institutes of Health to encourage research that contributes to preventing or reducing health disparities. If applicants are developing clinical trials related to health disparities research, they should refer and respond to the previously released NIDCR Clinical Trial Pilot Grant planning program announcement http://grants.nih.gov/grants/guide/pa-files/PAR-99-157.html. 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 Request for Applications (RFA) is related to oral health, which is one of the priority areas indicated in "Healthy People 2010". Other priority areas and their potential for reducing and ultimately eliminating oral health disparities should also be considered. These include nutrition, unintentional injury prevention, violence and abuse prevention, educational and community-based programs and access to care. Potential applicants may obtain "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, faith-based organizations, units of State and local governments, and eligible agencies of the Federal government. In order to capitalize on opportunities to increase the diversity of populations and topics addressed and to increase the number of institutions developing expertise in research relevant to oral health disparities, NIDCR will typically fund no more than one planning grant application in response to this RFA at any single institution. In addition, institutions with substantial funding that resulted from NIDCR Centers for Research to Reduce Oral Health Disparities RFA and applicants for the companion RFAs ("Pilot Grants to Prevent or Reduce Oral Health Disparities" and "Research Infrastructure and Capacity Building for Minority Dental Institutions to Reduce Oral Health Disparities") WILL NOT be eligible to apply for this planning grant. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. To be responsive to this RFA, an applicant must propose collaborative affiliations with other entities to address oral health disparities in under- represented populations. The collaboration can be with entities from within the institution as well as with other institutions. This collaboration should be for the purpose of facilitating and addressing the scientific objective that is the main focus of the research to be planned and used for increasing prospects for translating findings into sustainable programs should study findings indicate that a specific intervention does prevent or reduce oral heath disparities. Collaborations may include colleges, schools, departments, or organizations representing the spectrum of researchers (such as dental, social, genetic, molecular; nutrition, or clinical research epidemiologists; biostatisticians; anthropologists; and social and behavioral scientists), health professionals (such as physicians; physicians assistants; nurses; dentists; dental hygienists; nutritionists, community health workers), sectors which may influence health (such as health policy, urban planning, food and nutrition organizations and caterers, employers, social workers, nursing home administrators, school boards), or other academic institutions and State and Local health agencies and health financing agencies (such as state Medicaid, Medicare and third party payers). Other examples of collaborations include institutions that may serve as promoters of health through health policy, healthy literacy, or as alternative care delivery sites (such as infant, child or adult day care facilities, residential facilities and institutions, schools, worksites), or which maximize opportunities to nest oral health programs within larger health promoting activities (such as Healthy Communities, Healthy Cities, Healthy Schools, community-based participatory research projects, Women, Infant and Children Supplemental Food Program, Project Head Start, and faith-based initiatives). Interdisciplinary approaches are encouraged. The role of collaborations in fostering the project's continuation after the research phase must be discussed. Planning support is for new projects and may not be used to supplement research projects already being supported or to provide interim support for projects under review. Simultaneous submissions of applications for planning grants under this RFA and for the other two RFAs being simultaneously released will not be accepted. Applicants are encouraged to contact program staff listed on the RFA with questions they may have concerning the selection of the RFA most appropriate to their specific research interests, needs and goals. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Exploratory/ Developmental Research Grant (R21) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. Applicants may apply for continuation of projects developed under this program using traditional, unsolicited grant mechanisms (e.g., R01, IRPG). Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Funding under this RFA will be up to a maximum of $100,000 direct costs per year for up to a maximum of two years. For those applications that include a subcontractual/consortium arrangement, direct costs of up to $125,000 per year may be requested, in order to allow for F&A costs on those consortium arrangements, however this increase may be used only to offset the additional F&A costs for the subcontract consortium and for no other reasons. The anticipated award date is September 30, 2002. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE The NIDCR and NCMHD intend to fund in FY 2002 up to five new planning grants in response to this RFA. An applicant may request a project period for a maximum of two years and a budget of up to $100,000 in direct costs per year and up to $125,000 in direct costs for those applications that include a subcontractual/consortium arrangement. Although the financial plans of the Institute and Center provide for support of this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background Oral, dental and craniofacial diseases, disorders and conditions are amongst the most common health problems affecting children and adults of the United States and have been elucidated in "Oral Health in America: A Report of the U.S. Surgeon General" (U.S. Department of Health and Human Services, 2000) and the NIDCR "A Plan to Reduce and Eliminate Craniofacial, Oral, and Dental Health Disparities." Optimal prevention early detection, and treatment of oral diseases or conditions such as dental caries, orofacial and dental injuries, periodontal diseases, oral manifestations of or sequelae of other diseases and conditions such as diabetes, birth defects and other special needs and HIV infection, and oral and pharyngeal cancers are not readily available to many populations. Moreover, socioenvironmental, biological and behavioral factors combine with differential access to health care to create a disproportionately higher burden of craniofacial, oral and dental diseases and disorders in some population groups, including those who are poor and part of racial and ethnic minorities. Thus innovative yet sustainable approaches to prevent or reduce disparities warrant exploration. People in the United States who are poor continue to suffer from the consequences of oral diseases and conditions to a greater extent than those who have greater resources. America's poorest children have almost five times as much tooth decay as children of higher income families and nearly twice as many low-SES children 2-9 years of age have at least three decayed or filled primary teeth compared to higher SES children. Eighty percent of decay experienced by low-income children aged 2-5 years remains untreated. In addition, the rate of untreated dental caries is twice as high among low SES children than for those at higher income levels at ages ranging through adolescence. The disparity in the treatment of caries amongst the poor compared with the non-poor continues into adulthood. Periodontal diseases, which can at the most extreme result in the loss of all teeth, are also not distributed evenly amongst the poor and non-poor. About 14 percent of U.S. adults aged 45-54 and 23 percent of those aged 65-74 years old have severe periodontal disease that may put them at risk of loosing all of their teeth. As reported in the NIDCR "A Plan to Reduce and Eliminate Craniofacial, Oral, and Dental Health Disparities," adults at the lowest SES level had more severe periodontal diseases than the non-poor. Disparities in the prevalence of severe periodontal diseases amongst the poor and other segments of the population put them at greater risk to tooth loss and potentially to other serious conditions. Recent research has suggested that severe periodontal disease may have an impact well beyond those isolated to the oral cavity and include serious systemic consequences. The relationship between periodontal disease and diabetic control, preterm labor, and atherosclerosis are amongst the associations being explored. Disparities in oral health status exist by race and ethnicity in the United States as well. The NIDCR "A Plan to Reduce and Eliminate Craniofacial Health Disparities" reports that a higher proportion of poor Mexican-American children and non-Hispanic black children ages 2-9 have untreated primary teeth compared to poor non-Hispanic whites. The Plan goes on to report that the disparities are even greater when comparing non-poor minority children to white children of similar age and income status. The prevalence of early- onset periodontitis in 13-17 year olds occurs twice as often in African Americans than in Hispanics and ten times more frequently than in whites. With respect to adults, the proportion of untreated dental caries is higher amongst non-Hispanic blacks and Mexican Americans compared to their non- Hispanic white counterparts. A higher percentage of non-Hispanic Blacks across the adult life span exhibit at least one tooth site with severe periodontal attachment loss compared to other groups. Disparities also exist with regard to oral and pharyngeal cancer by race/ethnicity. African American men have a five-year survival rate for oropharyngeal cancer that is much lower (31% versus 55%) than that of white (SEER, 1999). The average age of diagnosis for African Americans is about ten years younger that that for whites, but only 19% of newly diagnosed oral and pharyngeal cancers in black men will be at the local stage as compared with 38 percent for white males. National data are limited for other oral, dental craniofacial conditions that can have serious consequences such as craniofacial injuries and disorders. It is known that there are more than 20 million visits to emergency departments for craniofacial injuries every year and close to six million orofacial injuries are treated by dentists in private dental offices. The leading causes of oral and craniofacial injuries are sports, violence, falls, and motor vehicle collisions. Differential wearing of protective sports headgear and mouthguards by school-aged children has been found amongst children whose parent's had lower education level, by females, and by race/ethnicity. But the differences were not consistent across sports. Domestic violence, child abuse, spousal and elder abuse, and abuse of the disabled are often manifested as injuries to the craniofacial tissues and dentition. There is a dearth of data for children and adults who have neurodevelopmental disabilities and other special needs though proceedings of a recent conference devoted to children with special needs indicate that the extent and severity of oral, craniofacial and dental diseases are serious. The conference proceedings also provide insight into the challenges faced by parents, caregivers and providers with respect to the prevention and treatment of oral, dental and craniofacial disease and conditions in special needs populations. Research conducted over the past half century has provided much insight into our understanding of some of the factors that contribute to oral diseases and conditions, as well as, methods for prevention and treatment in traditional clinical settings. However, the disparities that exist within segments of the U.S. population indicate that a better understanding of the interplay of biological, environmental and behavioral determinants of oral, dental and craniofacial diseases and conditions is needed. In addition, a full range of research into the development of new or innovative application of existing methods of prevention and treatment may be warranted. Many questions remain unexplored with respect to the determinants of disparities in oral health status amongst the poor, the geographically and otherwise isolated, and amongst racial/ethnic minorities. The impact of oral health status on oral health related quality of life and approaches to mitigate the impact needs investigation. The common risk/health factor approach, psychophysiology, social cohesion and social capital, and health literacy are but a few of the new areas being explored by social epidemiologists and others. While the testing of innovative models of delivering dental services is warranted, these approaches alone are unlikely to be sufficient to eliminate disparities in health. Equity in the receipt of traditional dental services that are available, accessible, affordable or acceptable may not be possible. Thus the sustainability of interventions once external research funding is diminished or ceases is a critical issue for preventing or reducing oral health disparities. Research Scope Current constraints on researchers make the complex and time-consuming process of planning research relevant to the prevention, reduction and ultimate elimination of oral health disparities challenging. Some of the challenges are the limited numbers of investigators with expertise in the numerous areas of research, which health promotion encompasses, lack of well- established research infrastructures and lack of interdisciplinary, multisectoral teams with expertise in research focused on the determinants of oral health disparities, community-based development and interventions, health care provision innovations or policy-related approaches to preventing, reducing and eliminating oral health disparities. These planning grants will provide a mechanism for early peer review of the overall rationale and general design of the potential oral health disparities research, and provide successful applicants resources to assist in the development of detailed study plans and collaborations. In addition, the planning grants are intended to help to facilitate single or multi-site research projects in areas of research relevant to specific populations of interest to the National Institute of Dental and Craniofacial Research, the National Center on Minority Health and Health Disparities and the Office of Research on Women's Health. Research that explores the broad array of determinants of disparities in oral, dental craniofacial status or that addresses a full range of health promotion approaches with the prevention or reduction of health disparities within under-represented populations are encouraged. The range of activities that may be supported by this planning grant includes the acquisition of data and analyses necessary to clarify/refine research question, the identification and development of a collaborative and resource base including the necessary human resource expertise, development of research questions / hypotheses, theory / conceptual framework to which the research will contribute, the development of the design of the study or studies and specific study protocol or protocols. In developing the research question (s) to be considered in this planning grant applicants may want to consider the following topics. The topics are not listed in priority order, nor are they comprehensive or restrictive. The final selection of a topic is the choice of the applicant. O Exploratory research to identify determinants of specific oral health disparities in understudied populations. Research across the broad spectrum of potential determinants could include such areas as gene/environment interactions, molecular variations, cultural factors, socioeconomic factors, health literacy level, social support, social cohesion, or other socioenvironmental and behavioral factors. O Studies designed to promote oral health and/or target underlying determinants of oral health disparities in understudied populations. Such studies may, for example, address biological issues such as nutrition or immune function, community, institutional or family-based approaches to promote health, strategies to strengthen community capacity or to modify health-influencing policies, such as youth access to smokeless tobacco, tobacco, methods to improve health literacy, approaches to reorient health services to allow for increased health care access and utilization of preventive services, methods to improve self-care behaviors and skill building. O Studies designed to prevent oral disease or conditions such as craniofacial and dental injuries, caries (coronal or early child hood caries) periodontal diseases, oral mucosal pathologies including oral pharyngeal cancers) in under-represented populations with oral health disparities. O Studies that explore novel and/or multidisciplinary approaches to the delivery of preventive and other health care services and their impacts upon oral health disparities. In addition, studies are encouraged to develop and test methods for accelerating the transfer of effective preventive or treatment methods and technologies into a full range of settings. O Studies designed to investigate factors contributing to the excess morbidity and mortality associated with craniofacial and oral diseases (e.g. periodontal diseases, oral and pharyngeal cancer and precancer, autoimmune diseases) or differences in responses to treatments within these populations. O Analyses of baseline data that are essential to establish the needed sample size and to evaluate the intervention outcome(s). O Studies of the impacts of disparities in oral health status on other outcomes such as overall health, nutrition, indices of quality of life, work loss or school absences or other social and economic outcomes and effects of interventions on these outcomes. O Studies of the genetic and molecular events/pathways and their interplay with physical, environmental, and other factors as these influence oral health disparities or interventions to influence their impacts, such as exposures to environmental toxins, sex/gender differences, genetic differences in scarring with implications for keloid formation and with implications for wound healing. Special Instructions Investigators are expected to demonstrate the scientific importance of the topic(s) they have selected and relevance to NIDCR's "A Plan to Eliminate Craniofacial, Oral, and Dental Health Disparities." Specifically, applicants must provide a context in which the planning grant is proposed, including a complete statement of the health disparity related problem in the specified population that a subsequent full scale (R01 type) study would address. To be responsive to this RFA, it is essential that the applicant document significant institutional and community support. Applicants are urged to insure that at least all of the review criteria are addressed in their applications. 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 sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH Phase III clinical trials that: a) all applications or proposals and/or protocols to 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 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. Program staff may also provide additional relevant information concerning the policy. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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. 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 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 NIDCR staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Nowjack-Raymer at the address listed under INQUIRIES, below, by March 21, 2002. APPLICATION PROCEDURES Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Applicants are strongly encouraged to contact one of the NIH program staff listed at the end of this document with any questions regarding the responsiveness of their proposed project to the goals of this RFA. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. The instructions in the PHS 398 application kit must be adhered to, except where they have been modified by the following Supplemental Instructions. Research Plan Do not exceed a total of 15 pages for the research plan (sections a-d). This limitation includes the introductory justification paragraph described below, tables and figures, but not sections e-1. Do not use the appendix to circumvent the 15 page limit by including tables or figures in the appendix that should appear in the research plan. As part of the description, applicants must identify briefly how this application relates to the purpose of the R21 mechanism as stated in this RFA. Special attention should be paid to explaining how the work proposed in the application will help contribute to understanding of the determinants of oral health disparities and/or intervening to prevent or reduce oral health disparities. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 should be sent to: Dr. George Hausch Scientific Review Branch Division of Extramural Activities National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44F Bethesda, MD 20892-6402 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: George.Hausch@nih.gov Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and for responsiveness to this RFA by NIDCR. 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 NIDCR in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may 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. 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 the application in order to judge the likelihood that the research planned could have a substantial impact on the pursuit of these goals particularly with respect to the prevention or reduction of oral health disparities. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward. Detailed information regarding the rationale for the studies being planned will be expected. Information necessary includes the health disparity (s) that exists, populations to be studied, and collaborative relationships to be developed with other researchers, community-based and other organizations, health and other agencies at the state or local level, health care practitioners, policy makers or other resources necessary to successfully implement the research being planned. (1) Significance: This criterion focuses on the research questions/aims to be addressed by a full scale (R01 type) study that would follow from the planning. Reviewers are asked to assess whether answers to the questions/aims posed for the full scale study are important ones with respect to reducing or preventing oral health disparities. Does this application address an under-represented population and a specific topic relevant to preventing or reducing oral health disparities? Is the main research question/aim of a subsequent full scale (R01 type) study an important question/aim that when addressed may ultimately help to prevent or reduce oral health disparities? What will be the effect of the results coming from that study in generating concepts, methods, or findings that provide the foundation for outcomes that prevent or reduce oral health disparities? (2) Approach: Does the applicant identify collaborative, infrastructure and human resource needs that are critical to carrying out the full scale (R01 type) study? Does the applicant acknowledge potential problem areas that will be addressed during the planning process, consider alternative approaches and discuss why the proposed approach is superior? Does the applicant demonstrate that once the planning is completed that a full scale (R01 type) study could be carried out? (3) Innovation: This criterion focuses on the full scale (R01 type) study resulting as an outcome of the proposed planning. If available, does the full 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? (4) Investigator: This criterion applies to the planning grant. The reviewers are asked to determine the following: Does the investigator, and/or other members of the research team, show adequate and appropriate expertise to conduct the work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? Have appropriate steps been outlined towards expanding infrastructure and collaboration for planning to conduct health disparities research on the topic identified? (5) Environment: This criterion applies to both the planning and the subsequent full scale (R01 type) study. In each case the reviewers are asked to determine the following: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposal take advantage of unique features of the scientific environment or plan to employ useful collaborative arrangements? Is there evidence of institutional, collaborative and community support? Is there evidence that the appropriate under represented population is available to the investigation? In addition to the above criteria, in accordance with NIH policy, applications also will be reviewed with respect to the following: O The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects also will be evaluated. O The reasonableness of the proposed budget and duration in relation to the proposed research. O The adequacy of the proposed protection for humans and the environment, to the extent they may be adversely affected by the project proposed in the application. SCHEDULE Letter of Intent Receipt Date: March 21, 2002 Application Receipt Date: April 18, 2002 Peer Review Date: June 2002 Council Review: August 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA Criteria that will be used to make award decisions include: o feasibility and adequacy of planning process to develop high quality scientific project (as determined by peer review) o availability of funds o programmatic priorities INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding scientific programmatic issues to: Ruth Nowjack-Raymer, M.P.H., Ph.D. Program Director Research to Reduce Oral Health Disparities Division of Population and Health Promotion Science National Institute of Dental and Craniofacial Research 45 Center Drive, Room 3AN-44D Bethesda, Maryland 20892-6402 Telephone: (301) 594-5394 Email: Ruth.Nowjack-Raymer@nih.gov Jean Flagg-Newton, Ph.D. Deputy Director 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 Phone: (301) 402-1366 Fax: (301) 402-7040 E-mail: flaggnej@od.nih.gov or jf41v@nih.gov Lisa Begg, Dr.P.H., R.N. Director of Research Programs Office of Research on Women's Health NIH Office of the Director 1 Center Drive, Room 201, MSC 0161 Bethesda, MD 20892 Phone: (301) 496-7853 Fax: (301) 402-1798 E-mail: beggl@od.nih.gov Direct inquires regarding review issues to: Dr, George Hausch Scientific Review Branch Division of Extramural Activities National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44A Bethesda, Maryland 20892-6402 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: George.Hausch@nih.gov Direct inquiries regarding fiscal matters to: Mr. Kevin Crist Grants Management Branch Division of Extramural Activities National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44A, Bethesda, Maryland 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8301 Email: Kevin.Crist@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121 (NIDCR) Oral Diseases and Disorders Research Awards. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant 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.

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