PILOT GRANTS FOR RESEARCH TO PREVENT OR REDUCE ORAL HEALTH DISPARITIES Release Date: Janaury 11, 2002 RFA: RFA-DE-02-004 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) National Institute of Nursing Research (http://www.ninr.nih.gov) 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 National Institute of Nursing Research (NINR) invite applications for pilot research focusing on the determinants, prevention/reduction, or impacts of oral health disparities in populations currently under-represented in NIDCR"s grant portfolio. This RFA is being issued concurrently with two other RFAs ("Planning Grants for Research to Prevent or Reduce Oral Health Disparities" DE-02-005 and "Research Infrastructure and Capacity building for Minority Dental Institutions to Reduce Oral Health Disparities" DE-02-003). Together they reflect a strong commitment on the part of the National Institutes of Health to encourage research that contributes to preventing or reducing health disparities. 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. Support provided through this mechanism may include testing of research methods and instruments as well as collection of preliminary data in these populations. The ultimate aim of the pilot study should be to develop a sound scientific foundation for subsequent R01-level single or multi-site studies to prevent or reduce oral health disparities. Awards under this RFA are not intended to support or supplement ongoing research or serve as an alternative mechanism of support for projects not receiving funding as competitive applications. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This RFA "Pilot Grants for Research to Prevent or Reduce Oral Health Disparities" is related to oral health, which is one of the priority areas indicated in "Health People 2010". Other priority areas and their potential contributions toward reducing and ultimately eliminating oral health disparities should also be considered. Examples include nutrition, unintentional injury prevention, violence and abuse prevention, tobacco use, educational and community based programs, and access to health care. Potential applicants may obtain a copy of "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, 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 expanding their research efforts or research capacity relevant to oral health disparities, NIDCR will typically fund no more than one pilot grant application in response to this RFA at any single institution. It should be noted that applications for this RFA will not be accepted from institutions with significant funding from the NIDCR Centers for Research to Reduce Oral Health Disparities RFA, nor will pilot grant applications be accepted from institutions responding as primary applicants to the two companion RFAs focused on developing research capacity in minority dental schools and/or fostering research planning for investigators who consider themselves not as yet fully ready to implement pilot research projects. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. If applicants are developing clinical trials relevant to health disparities research, they should refer to and respond to the previously released NIDCR Clinical Trial Pilot Grant program announcement (http://grants.nih.gov/grants/guide/pa-files/PAR-99-158.html.) Applicants are encouraged to contact program staff listed on this RFA with questions they may have concerning which RFA best matches their needs and goals MECHANISM OF SUPPORT This RFA invites grants for support through the National Institutes of Health (NIH) Exploratory/ Developmental Grant (R21) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Funding under this RFA will be up to a maximum of $125,000 direct costs per year for up to a maximum of three years. For those applications that include a subcontractual/consortium arrangement, direct costs of up to $175,000 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. This RFA is a one-time solicitation. Awards are not renewable and supplements will not be allowed. The anticipated award date is September 30, 2002. Use of the R21 mechanism for pilot studies is intended, in part, to encourage innovative new research directions and exploration of approaches and concepts new to a particular area or study population. As such, this mechanism can encourage the entry of investigators to a field, extend the range of research support on a topic, and encourage new research approaches, new collaborations, or research with new or under-studied populations. Applications will typically be expected to provide less preliminary data than would be the case for other funding mechanisms. Applicants should, however, make clear that the proposed pilot research is scientifically sound, that the long term research goals are both scientifically significant and relevant to the aim of preventing or reducing oral health disparities, that the qualifications of the investigators are appropriate, and that resources available to the investigators are adequate for the work proposed. Those applicants that are not at the point of conducting pilot research but rather need to develop plans and collaborative arrangements that will provide a sound foundation for conducting scientifically meritorious studies to prevent or reduce oral health disparities are encouraged to refer to the planning grant RFA that is being released simultaneously. FUNDS AVAILABLE The NIDCR and NCMHD intend to fund in FY 2002 up to seven new pilot grants in response to this RFA. An applicant may request a project period for a maximum of three years and a budget of up to $125,000 in direct costs per year and up to $175,000 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 program, awards resulting from this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background "Oral Health in America: A Report of the Surgeon General" (2000) indicates that oral, dental, and craniofacial diseases and disorders are among the most common health problems affecting people in the US. Many population subgroups in our society lack access to optimal prevention, early detection, and treatment of oral diseases or conditions such as early childhood caries, dental caries, periodontal diseases, oral and pharyngeal cancers, orofacial and dental injuries, oral manifestations or sequelae of other diseases such as HIV infection or diabetes, and birth defects affecting the dental and craniofacial structures. Moreover, biological, behavioral, and socioenvironmental 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 racial and ethnic minorities and those who are poor. Difference in the prevalence of diseases and conditions exist by gender as well. While gains have been made in the oral health status of Americans over the past decade, not all groups have demonstrated comparable benefit. This disparity in oral health among diverse populations has become a major focus of the research supported by NIDCR as outlined in NIDCR"s "A Plan to Eliminate Craniofacial, Oral and Dental Health Disparities." People in the United States who are poor suffer from the consequences of oral diseases and conditions to a greater extent than do those with greater resources. America"s poorest children have nearly five times as much tooth decay as children of higher income families. 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. Disparities in caries treatment for the poor as compared with the non-poor continue into adulthood. Periodontal diseases, which can ultimately result in the loss of all natural teeth, disproportionately affect the 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 losing all of their teeth. As reported in the NIDCR "A Plan to Eliminate Craniofacial, Oral, and Dental Health Disparities," adults with the lowest at the lowest SES level had more severe periodontal diseases than the non-poor. Disparities in the prevalence of severe periodontal diseases among the poor and other segments of the population put them at greater risk for tooth loss, impaired nutrition and quality of life, and potentially 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 being explored. In the US racial and ethnic disparities in oral health status also are common. For example, 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. These disparities are even greater when comparing non-poor minority children to white children on 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 exhibited 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% vs 55%) than that of whites (SEER, 1999). The average age of diagnosis for African Americans is about 10 years younger than 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. Domestic violence, child abuse, spousal and elder abuse, and abuse of the disabled are often manifested as injuries to the craniofacial tissues and dentition, but epidemiological data remains meager. There is also a dearth of oral health data for children and adults who have neurodevelopmental disabilities and other special needs, although 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 provides insight into the daunting 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 to date has contributed to our understanding of some of the factors that contribute to oral diseases and conditions and has yielded more effective clinical measures that can be used in health care settings to prevent or treat oral diseases. However, the striking oral health disparities which persist within segments of the U.S. population suggest the need for a better understanding of the interplay of biological, environmental, and behavioral determinants of oral, dental and craniofacial diseases and conditions. Intervention research, including that which addresses policy, environmental or institutional changes that could contribute to potentially sustainable positive outcomes, may be warranted. Collaborations with other academic institutions, schools, faith-based and other community organizations, or with local, community, or state public health agencies may be necessary to increase prospects for reducing or preventing oral health disparities. Goals and Scope A primary goal of this RFA is to stimulate pilot research which will develop sound methods and preliminary data which will serve as the foundation for subsequent full scale (R01 type) supported research to prevent or reduce oral health disparities in populations under represented in NIDCR"s health disparities portfolio. In developing the research question (s) to be considered in such research, applicants should refer to NIDCR"s "A Plan to Eliminate Craniofacial, Oral and Dental Health Disparities" (http://www.nidcr.nih.gov/research/health_disp.asp). Listed below are illustrative topics. The topics are not presented 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, 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, 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 or genetic differences in keloid formation with implications for scarring and implications for wound healing. SPECIAL REQUIREMENTS 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 Disparities." Specifically, applicants must provide a context in which the pilot 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, an experimental or other appropriate study design to address that problem, and the gap in knowledge that needs to be filled via the pilot research proposed in this application before the subsequent full scale (R01 type) study can be launched. Applicants are also expected to show that they are ready to initiate relevant pilot studies, as indicated, for example, by their demonstrable access to appropriate study populations and the scientific quality and appropriateness of the pilot studies they propose. In addition, 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 the RFA to which the application is responding. 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 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 must also be sent to: H. George Hausch, Ph.D. 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 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 the CSR and responsiveness by program staff of the participating institutes. 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 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 proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (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 pilot research. 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 study address a population and topic relevant to reducing oral health disparities? Is the main research question/aim of a subsequent full scale (R01 type) study an important question/aim that when answered 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 gaps that are critical to carrying out the full scale (R01 type) study? Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate? Does the applicant acknowledge other potential approaches and discuss why the proposed project is superior? To what degree will support of the proposed pilot study help develop an initial database for future research to prevent or reduce oral health disparities? Does the applicant demonstrate that once the pilot study is completed 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 pilot study: 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 for both the pilot study and the subsequent full scale (R01 type) study. In each case the reviewers are asked to determine the following: Is the investigator appropriately trained and well suited to carry out the work? Does the investigator and/or other members of the research team show adequate and appropriate expertise to conduct the research? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers? (5) Environment: This criterion applies for both the pilot study 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 proposed research take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional 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, all applications will also 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 will also 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, animals or 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 Scientific Review Date: May/June, 2002 Advisory Council Review: August 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities INQUIRIES Inquiries concerning this RFA are encouraged. Applicants are encouraged to ask questions or seek any information they may need to clarify the goals or requirements set forth in this solicitation. Direct inquiries regarding 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 Sciences National Institute of Dental and Craniofacial Research 45 Center Drive, Room 3AN-44D Bethesda, MD 20892-6401 Telephone: (301) 594-5394 FAX: (301) 480-8254 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 Janice Phillips, Ph.D., FAAN Program Director Health Promotion, Risk Reduction and Oncology Research Office of Extramural Programs National Institute of Nursing Research Building 45, Room 3AN12 Bethesda, MD 20892-6300 Telephone: (301) 594-6152 FAX: (301) 480-8260 Email: Janice.Phillips@nih.gov Direct inquiries regarding review issues to: H. George Hausch, Ph.D. Scientific Review Branch Division of Extramural Activities National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44A Bethesda, MD 20892-6402 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: George.Huasch@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, MD 20892-6402 Telephone: (301)-594-4800 FAX: (301) 480-8301 E-mail: Kevin.Crist@nih.gov Ms. Cindy McDermott Chief Grants Management Officer National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6869 FAX: (301) 451-5648 E-mail: mcdermoc@mail.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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