TRANSLATIONAL RESEARCH IN DENTAL PRACTICE-BASED TOBACCO CONTROL INTERVENTIONS RELEASE DATE: October 7, 2002 RFA: DE-03-007 National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) LETTER OF INTENT RECEIPT DATE: February 24, 2003 APPLICATION RECEIPT DATE: March 24, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Purpose of This RFA o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute on Drug Abuse (NIDA) and the National Institute of Dental and Craniofacial Research (NIDCR) are committed to stimulating innovative research on dental practice-based tobacco control interventions, as well as studies which use dentistry as a model to clarify processes underlying or influencing the translation of research findings into clinical practice. Tobacco control provides an important, public health-relevant venue for studying the translation of basic and clinical research findings into clinical practice. Clear, science-based clinical guidelines for implementing tobacco prevention and tobacco cessation are available. Also, numerous studies have documented harmful impacts of tobacco use on oral diseases and dental treatment outcomes. As yet, however, evidence suggests that the preponderance of US dental clinicians are not utilizing optimal science-based approaches to prevent or reduce the use of oral health- harming smoked or smokeless tobacco products. This RFA aims to stimulate research to: 1) develop and test interventions that translate findings from alcohol, tobacco and other drug prevention and treatment research into effective, dental practice- based tobacco control strategies, 2) translate findings from other theoretically-grounded basic or behavioral science research into effective dental practice-based tobacco control strategies, or 3) clarify processes that underlie or influence the translation of tobacco-related knowledge into clinical dental practice. RESEARCH OBJECTIVES Background The initiation of smoked or smokeless tobacco use is promoted by a wide array of familial, peer, community and media factors. Ongoing use is maintained primarily by the addictive nature of nicotine, although other constituents of tobacco products also play a role. In addition, cues that have become conditioned to the use of tobacco can influence subsequent use, as well as the relapse to use that often accompanies quit attempts. Epidemiological studies indicate that experimentation with tobacco products typically begins in early adolescence. Addiction often develops rapidly, with the presence of addiction often demonstrable early in an individual's history of use. Thus, preventing initiation of tobacco use is critical. Various preventive strategies involving family, peer and school, community, or media influences have been studied and found to influence use, age at initiation of tobacco use, and relative probabilities of tobacco use and addiction in adulthood. Treatment of tobacco addiction in adults typically incorporates behavioral support strategies in conjunction with nicotine replacement therapies (NRT), such as the nicotine patch, polacrilex gum, or Zyban (bupropion). Contemporary treatment research is exploring other approaches, for example medications such as clonidine, nortryptiline, and combinations of bupropion with NRTs. I. Changing clinicians' practice behaviors related to preventing, reducing, monitoring, or treating tobacco use/nicotine addiction. In theory, front-line clinicians are in an ideal position to identify problematic health behaviors and to intervene promptly via preventive or treatment strategies and/or referral. Evidence from randomized trials and observational studies demonstrates that health care providers who intervene with smokers can reduce their patients' tobacco use. Various approaches to help patients quit smoking have been demonstrated to be effective in outpatient health care settings. Quit rates generally become higher as the interventions offered by the health provider become more frequent and intensive. Multi-modality interventions, including identification, counseling, education, pharmacological aids, and follow-up have more powerful and consistent behavioral effects than do unidimensional approaches, such as advice alone. Brief clinic-based interventions have been shown to increase patient smoking cessation rates. In 1989, the National Cancer Institute developed recommendations for physicians treating patients who smoke. This recommended approach includes four steps – ask about smoking, advise smokers to stop, assist those who want to stop, and arrange adequate follow-up. In 1996, the Agency for Health Care Policy Research (now the Agency for Health Research Quality) recommended a five-step approach as a guideline for primary care providers. Similar to the original approach, it integrates an additional step, that of assessing the patient's willingness to stop, after the provider has already asked about tobacco use and advised the patient to quit. Several studies have shown that brief advice on smoking cessation, delivered either by physicians or dentists, produces demonstrably beneficial overall reductions in tobacco use. Research has also shown that the effectiveness of provider-delivered smoking cessation interventions is increased by training, the use of screening systems or chart identifiers to indicate patients' tobacco status, and the use of cues or reminders to intervene with smokers. While practice-based screening and treatment to reduce use of tobacco products are effective, tobacco control interventions remain under- utilized in both medical and dental settings. Some significant barriers to implementing tobacco or substance abuse screening or interventions in health care settings have been identified. Barriers clinicians report include: patient resistance and alienation, low success rates, lack of time, lack of reimbursement, lack of organizational support, and lack of appropriate patient education materials and referral resources. Findings indicate that many primary care providers do not see themselves as adequately prepared or competent to treat smokers or other patients with substance abuse problems. Engaging in training and educational programs has, however, been demonstrated to change practice behaviors. For example, physicians who had received formal training in smoking cessation were observed to spend more time counseling patients to quit smoking than did their counterparts who lacked this extra training. Similarly, a brief training program teaching internal medicine and family practice residents to counsel patients to stop smoking resulted in increasing both their observed cessation counseling skills and their reported willingness to employ these techniques later. II. Tobacco Use and Oral Health. Tobacco use has serious, costly adverse effects on oral health. Studies indicate that all forms of tobacco, including cigarettes, cigars, pipes and smokeless tobacco products, can cause oral and pharyngeal cancers. Smoking is known to be a major risk factor in adult periodontitis. Strong epidemiological and clinical evidence supports the view that fully one-half of the periodontitis cases in the US can be attributed to cigarette smoking and that tobacco use increases risks for a wide range of oral soft tissue changes. Tobacco use also substantially reduces probabilities of successful outcomes from periodontal therapies and dental implants, impairs oral wound healing, and creates tooth discoloration and other oral changes which help fuel demand for costly dental interventions. The American Dental Association (ADA) Summary of Policy and Recommendations Regarding Tobacco, (http://www.ada.org/prof/prac/issues/statements/tobac.html) "…urges its members to become fully informed about tobacco cessation intervention techniques to effectively educate their patient to overcome their addiction to tobacco". However, there is limited evidence that this policy statement has been widely implemented. Findings from the ADA's 1997 Survey of Current Issues in Dentistry: Tobacco Cessation Efforts Among Dentists indicate that 60% of respondents reported they routinely asked about tobacco use and 40% reported they routinely advised tobacco users to quit. (However, dentists interested in tobacco cessation may have been more likely to respond to the survey). In contrast, a recent study of dental patients revealed that only 24% of smokers and 18% of smokeless tobacco users who had seen a dentist in the past year reported that their dentist had advised them to quit. Recently published U.S. Public Health Services clinical guidelines on treating tobacco use and dependence provide evidence-based, practical methods which dental professionals can utilize. Despite the availability of such guidelines, their translation into practice has lagged and little research has focused on developing the means to accelerate this process. Recent studies indicated that about one-half of dental schools include didactic training in counseling tobacco users to quit, and less than one-half of dental school clinics and dental hygiene programs provide any significant level of clinical tobacco intervention services. Studies from the mid-1990s indicated that at that time only 25% of dental schools were using health history forms that included any questions about tobacco use. U.S. survey data for 1996-1997 indicates that 63 percent of adults aged 18-65 years and 72% of youth 5-18 years had a dental visit during the past twelve months. Moreover, many dental visits are regularly scheduled and preventively oriented, typically involve longer intervals of interaction than most medical visits, and often dental patients return to the same dental providers regularly across years or even decades. Thus, members of the dental profession may be well positioned to make a unique contribution to influencing tobacco use and reinforcing sustained reductions in tobacco use in a substantial proportion of America's youth and adults. III. Adoption/Diffusion. Research on the dissemination of information to health care providers indicates that printed materials (including journal articles) seldom have a strong effect on providers' behavior. Based on models of behavior change, information alone is often not sufficient to produce enduring behavioral changes. Additional steps are often required to help motivate, facilitate, and reinforce changes in entrenched behaviors. From the complementary perspectives of social influence research, health care providers' behaviors are also accessible to change through addressing regulatory, normative, economic, and peer influences. Examples of regulatory influence include third party reimbursement policies, the threat of malpractice and sanctions by peer review or other authoritative bodies. Normative influences are especially critical during the early professional training of health care providers. Interventions conducted during professional training or bridging the transition between training and early years of practice provide some unique opportunities to test impacts of normative influences on subsequent practice behaviors. In contrast, different strategies and interventions may be more powerful in changing the clinical practice behaviors of well-established, experienced health care providers. Research addressing the translation of tobacco control strategies into practice at various points throughout dental providers' career trajectories is specifically encouraged. Scope This RFA is intended to stimulate well-designed translational research that can ultimately provide the basis for more effective tobacco control efforts by dental professionals within a wide array of dental health care delivery settings. Studies focused on identifying key processes influencing translation of effective tobacco prevention/cessation strategies into clinical dental practice, as well as intervention research to test and improve tobacco prevention and cessation measures within dental settings are specifically encouraged. A number of basic science research themes are potentially applicable to developing more effective dental-practice based tobacco interventions. Also, prevention and treatment strategies shown to be effective as applied to other health conditions may prove applicable within dental settings to help prevent tobacco initiation, or to reduce dental patients' tobacco dependence and addiction. Studies may test innovative approaches to accelerate dental care providers' adoption and maintenance of effective tobacco control procedures, such as preventing tobacco use in non-users, helping current users to quit, providing long-term feedback and reinforcement to maintain non-use, and educating dental patients and the public regarding specific oral health risks associated with tobacco use. To the extent feasible, translational studies should be grounded in theory and test both immediate and longer-term effects. Investigators may focus on interventions initiated during the professional education process or early clinical training, at the transition between training and professional practice, or within established dental practice settings. This RFA also encourages studies targeting changes in tobacco-related knowledge, attitudes and practices of practicing dental professionals, including dental hygienists, working with different patient populations and within different practice settings (e.g., dental HMO, general or specialty dental practice settings). Cross-disciplinary research projects that foster collaboration between basic and clinical researchers are specifically encouraged. Illustrative examples of studies appropriate to this initiative include the following: o Identify and test measures to accelerate translating basic or clinical science findings on health risks of tobacco use and effective approaches for tobacco prevention and cessation into more widespread clinical practice, using dentistry as a model; o Develop and test interventions aimed at translating findings from drug dependence and addiction research into dental practice-based tobacco control strategies; o Study factors influencing the adoption and acceptability of dental practice-based prescription of nicotine replacement therapies or other drugs which have been demonstrated to improve tobacco quit rates; conduct intervention studies to increase the acceptability and effective use of such therapies in dental settings; o Identify and characterize determinants of dental professionals' adoption, implementation, and long-term maintenance of practice behaviors congruent with evidence-based clinical guidelines for tobacco prevention and cessation; o Use untapped findings on cognitive factors such as decision-making, automatic vs. controlled thinking, affective mediators and modulators of cognition to help develop and pilot test innovative tobacco prevention and cessation programs and to develop more effective strategies that can be used in clinical dental practice; o Identify relationships between dental providers' levels of knowledge concerning the oral health effects of tobacco and their clinical decision-making and practice behaviors; o Refine and test methods and results associated with delivering motivational interviewing or other tobacco counseling approaches within dental settings, and test such interventions involving various dental team members; o Develop and test methods that capitalize on the known effects of tobacco use on dental treatment outcomes and/or diminished dental treatment options as a result of the patient's continued tobacco use (e.g., poor prognosis for successful dental implants, premature tooth loss in diabetic patients) to help motivate reduced use of tobacco products or tobacco cessation in special patient groups; o Adapt, develop, test, and compare the effectiveness of training programs intended to influence dental health providers' attitudes, knowledge, and skills concerning dental practice-based tobacco prevention or cessation, providing particular attention to the assessment of longer term changes in actual practice behaviors. This list is illustrative and not intended to be inclusive. Investigators are encouraged to propose other studies related to the adoption and translation of science-based tobacco control measures within dental educational and dental practice settings. They are also encouraged to contact the NIDCR and NIDA research/science staff listed later in this RFA with specific questions they may have regarding whether a topic is responsive. For purposes of this RFA, NIDA will assume primary programmatic responsibility for all applications involving phase I or phase II clinical trials. Moreover, the applicant needs to consult with NIDA program staff prior to the preparation of any such application. MECHANISM OF SUPPORT Applicants responding to this RFA may use the NIH Research Project Grant (R01) or Exploratory/Developmental Grant (R21) award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 1, 2003. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting format (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less use the modular format. Otherwise follow the instructions for non-modular research grant applications. R21 applications only: Use of the R21 mechanism to support pilot studies is intended to encourage innovative new research directions and the exploration of approaches and concepts new to a particular area or study population. As such, this mechanism encourages the entry of investigators to a field, as well as encouraging new research approaches and new collaborations. R21 applications will 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 tobacco control, the qualifications of the investigators are appropriate, and resources available to the investigators are adequate for the work proposed. An R21 grant cannot be renewed. If additional research support is necessary, investigators could then apply for further funding through the regular research grant (R01) mechanism. FUNDS AVAILABLE NIDCR and NIDA intend to commit a total of $2,000,000 in FY2003 to fund 6 to 8 new grants in response to this RFA. An applicant may request a project period of up to 2 years for an R21 or up to 5 years for an R01 application. R01 applicants may request a budget for direct costs of up to $375,000 per year. An R21 applicant may request a project period of up to 2 years and a budget with direct costs of up to $150,000 (6 budget modules) per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIDCR and NIDA include support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) R01 or R21 application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of state and local governments o Eligible agencies of the Federal government Foreign institutions are not eligible under this RFA; however, a domestic institution may, as scientifically appropriate, propose research that includes foreign components. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Grantees will be expected to attend a one and one-half day meeting annually at or near NIH, Bethesda, MD, to share results and provide an opportunity for collective problem solving. Applicants should budget travel funds to attend this annual meeting in their requested budget. The travel costs requested should be sufficient to permit attendance by either the principal investigator and one additional investigator (for R01 awards) or the principal investigator solely (for R21 awards). WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: Direct scientific/research questions related to tobacco prevention and control studies within dental educational settings or involving the transition from professional education into clinical practice to: Patricia S. Bryant, PhD Director, Behavioral and Social Sciences Research Program Clinical, Epidemiology and Behavioral Research Branch Division of Population and Health Promotion Sciences National Institute of Dental and Craniofacial Research National Institutes of Health 45 Center Drive, Room 4An24E Bethesda, MD 20892-6402 Telephone:(301)594-2095 Fax:(301) 480-8318 Email: Patricia.Bryant@nih.gov Direct scientific/research questions related to tobacco prevention and control studies involving dental clinicians within private dental practice settings or other dental care delivery settings to: Maria Teresa Canto, DDS, MPH Director, Population Sciences Research Program Clinical, Epidemiology & Behavioral Research Branch Division of Population and Health Promotion Sciences National Institute Dental & Craniofacial Research National Institutes of Health 45 Center Drive, Room 4AN24K Bethesda, MD 20892-6401 Telephone:(301) 594-5497 Fax: (301) 480-8319 E-mail: maria.canto@nih.gov Direct scientific/research questions related to the translation of basic science findings into practice-based tobacco research or relevant clinical trials within dental settings to: Herbert Weingartner, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse National Institutes of Health 6001 Executive Blvd. Bethesda, MD 20892-9555 Telephone 301-435-1321 Fax 301-594-6043 E-mail: herbw@nih.gov Direct scientific/research questions related to the translation of research on the treatment of drug use, dependence, or addiction into tobacco interventions or relevant clinical trials within dental settings to: Debra Grossman, M.A. National Institute on Drug Abuse National Institutes of Health 6001 Executive Boulevard, Room 4123 Bethesda, MD 20932 Telephone: (301) 443-0107 Fax: (301) 443-6814 E-mail: dg79a@nih.gov Direct scientific/research questions regarding the translation of research on the prevention of drug use, dependence, or addiction into tobacco interventions or relevant clinical trials within dental settings to: Shakeh Jackie Kaftarian, Ph.D. Health Scientist Administrator National Institute on Drug Abuse National Institutes of Health 6001Executive Blvd, Rm 5153 Rockville, MD 20852 Telephone:301-443-8892 Fax: 301-480-2542 E-mail: jk362j@nih.gov Direct questions about peer review issues to: H. George Hausch, Ph.D. Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN-44F Bethesda, MD 20892-6402 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: George.Hausch@nih.gov Direct questions about financial or grants management matters to: Anne Welkener Acting Chief Grants Management Office Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN-44K Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8303 Email: Ann.Welkner@nih.gov Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse National Institutes of Health 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to Dr. Hausch at the address listed above. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. For R21 applicants, PHS 398 requirements should be followed, with the exception of those specific modifications provided for in the R21 application instructions provided at the URL http://www.nidcr.nih.gov/funding/rfa/r21applications_nida.asp. R01 or R21 applications not conforming to the requested format will be returned to the applicant without review. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year 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. Applicant request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://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: https://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: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: H. George Hausch, Ph.D. Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN-44F Bethesda, MD 20892-6402 APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e., FEDEX, UPS, DHL, etc.). This change in practice is similar and consistent with the policy for applications addressed to the Centers for Scientific Review as published in the NIH Guide Notice https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the participating ICs. 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: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Dental Research Council and the National Advisory Council on Drug Abuse. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does 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, or employ innovative approaches for assessing sustainability within health care delivery settings? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 24, 2003 Application Receipt Date: March 24, 2003 Peer Review Date: June/July 2003 Council Review: August 2003 Earliest Anticipated Start Date: September 1, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at https://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (HESC): Criteria for federal funding of research on HESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using HESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s) for the HESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Specifically it addresses Healthy People 2010 objectives related to oral health, drug dependence and addiction, and tobacco. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Nos. 93.121 (NIDCR) and 93.279 (NIDA) and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES Applicants may wish to view selected references, which are available at the following URL (http://www.nidcr.nih.gov/funding/rfa/references_nida_r21.asp)

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