RFA-DE-04-005: STATE MODELS FOR ORAL CANCER PREVENTION AND EARLY DETECTION

STATE MODELS FOR ORAL CANCER PREVENTION AND EARLY DETECTION - PHASE II RELEASE DATE: June 23, 2003 RFA: DE-04-005 National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov) National Cancer Institute (NCI) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER (S): 93.121 (Oral Diseases and Disorders), 93.399 (Cancer Control) LETTER OF INTENT RECEIPT DATE: November 14, 2003 APPLICATION RECEIPT DATE: December 17, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o 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 of Dental and Craniofacial Research (NIDCR, NIH, DHHS) and the National Cancer Institute (NCI, NIH, DHHS) invite applications for research grants to design, implement and evaluate interventions for oral cancer prevention and early detection. The interventions must be based on a state needs assessment for these cancers among the public and providers. Goals of these interventions are to raise awareness about oral cancer risk factors and prevention and to promote the early detection of oral malignancies. The needs assessment could have been funded by the NIDCR or other sources. RESEARCH OBJECTIVES In 2002 it was estimated that oral and pharyngeal cancers would account for 28,900 cases and 7,400 deaths in the United States (Jemal et al., 2002). More than 90% of oral cancers occur in individuals 45 years of age and over (Ries et al., 2002). Recently, reports indicate an increase in tongue cancer among younger individuals (Myers et al., 2000; Pitman et al., 2000). Although males are more likely than females to develop these cancers, the male to female ratio decreased form 6:1 in 1950 to 2:1 in 1987 and this ratio has remained constant to the present (Horowitz et al., 1996 ; Ries et al., 1999). The age- adjusted incidence rate for total oral cavity and pharynx cancers was 10.3 per 100,000 population in 1999 (Ries, et al., 2002). This incidence rate represents approximately 3% of all cancers in the United States. The overall five-year survival rate is 53%, and it has not changed in the past thirty years (Silverman, 2001; Canto and Devesa, 2002). This five-year survival rate represents one of the lowest five- year survival rates of any of the major cancer sites. These low survival rates may be attributed to the fact that these cancers tend to be diagnosed at advanced stages. Moreover, the treatment for these malignancies are extremely disfiguring and often result in severe loss of function including inability to swallow and impairment of speech. Major risk factors for oral cancers in the United States are use of tobacco and alcohol. Use of these two products account for 75% of all oral cancers (Wynder et al., 1977). Lip cancer, on the other hand, is primarily associated with sun exposure. Other risk factors for oral cancers include malnutrition or poor dietary intake of essential minerals. For example, Plummer-Vinson syndrome, an iron deficiency, may place women at risk of oral cancers (Devesa et al., 1990). Other risk factors include exposure to viruses such as human papillomavirus (Gillison et al., 1999) and Epstein-Barr virus (Yu MC, 1996). In addition, a case-control study suggests that marijuana use may increase the risk for head and neck cancer (Zhang et al., 1999). Conversely, lower risk of oral cancers is associated with an increased consumption of fruits and vegetables (Potter et al., 1997). Thus, primary prevention measures include: 1) avoiding tobacco products, 2) limiting the intake of alcoholic beverages, 3) eating a diet rich in fruit and vegetables and 4) avoiding exposure to certain viruses (oral sex) and sunlight. Secondary prevention consists of a visual and tactile examination of the oral cavity, head and neck, which is essential for early detection. Because of the significant morbidity and mortality associated with the diagnosis of oral cancer at advanced stages, the American Cancer Society (ACS) recommends an oral cancer examination every 3 years for individuals over age 20 and annually for persons 40 years of age or older (Smith et al., 2002; Horowitz, et al., 1996). The U.S Prevention Services Task Force recommends that clinicians include a careful examination/screening for oral cancer in asymptomatic individuals who use tobacco or alcohol (DiGuiseppi et al., 1996). An oral cancer examination poses little discomfort for the patient and is noninvasive. Although dentists and dental hygienists generally perform this type of examination/screening, other health care providers (i.e., nurse practitioners, physician assistants, physicians) could provide an oral cancer examination as part of a routine physical. Involvement of the latter health care providers is essential because many individuals in high-risk groups visit them more frequently than a dentist or dental hygienist. A national survey of US dentists' knowledge and opinions concerning oral cancers indicated that the majority of dentists identified most of the real risk factors for oral and pharyngeal cancers (i.e., tobacco, age, prior cancer) while only 33% knew that oral cancers are most often diagnosed in late stages (Horowitz et al., 2000). In this survey, recent graduates of dentistry were found to be better informed. The results of the national survey of dental hygienists were similar to the national survey of dentists regarding knowledge of the major risk factors for oral and pharyngeal cancers. However, some deficiencies were identified regarding oral cancer diagnostic procedures among dentists and dental hygienists. Some did not feel adequately trained to perform an oral cancer examination, especially palpating lymph nodes (Forrest et al., 2001). These national surveys also addressed the age group of patients receiving an oral cancer examination/screening and included questions on oral cancer risk factors assessed by the health provider when obtaining the patient's medical history. Eighty-eight percent of dentists indicated they did not provide an oral cancer examination/screening for edentulous patients 18 years of age or older. Eighty one percent provided an oral cancer examination/screening to all their dentate patients above 40 years of age during the initial visit (Yellowitz et al., 2000). In regards to oral cancer risk factors, current use of tobacco products was a question consistently asked by dentists and dental hygienists. Only 75% of dentists asked about past use of tobacco products while 70% asked about types and amount of tobacco products used. In addition, less than 50% of oral health professionals inquired about current and past use of alcohol products (Horowitz, et al., 2000). The 1990 National Health Interview Survey (NHIS), Health Promotion and Disease Prevention Supplement (HPDP) included four questions about oral cancers. This study revealed that the US adult public is not well informed about signs of oral cancers (Horowitz et al., 1995). In addition, the 1992 National Center for Health Statistics (NCHS) Cancer Supplement Survey found that only 14% of the public had ever been examined for oral cancers and only 7% in the past year. A survey conducted in the state of Maryland found a low level of knowledge about risk factors for and signs and symptoms of oral cancers. In this survey, only 28% of respondents reported ever having an oral cancer examination; and, of these, only 20% had an oral cancer examination in the past year (Horowitz et al., 1998). Lack of adequate knowledge by the general public was partially explained by minimal coverage of oral cancers in popular magazines and newspapers (Canto et al., 1998b) and limited availability of oral cancer educational materials designed for the public (Chung et al., 2000). To achieve the Healthy People 2010 objectives, changes must be made at the state level since oral cancer awareness and practices by the general public and health professionals may differ from one state to another. The particular demographics of a state have an impact on the most relevant interventions and activities to reduce the burden from oral cancers. In addition, state health professions practice acts will determine which group of allied health personnel can provide oral cancer examinations/screening. Thus, a state model approach for oral cancer prevention and early detection is recommended to reach a large segment of health professionals and the public including those groups at high risk. Further, the interventions must be tailored to the particular needs of that state. Goals and Scope The purpose of this Request for Applications (RFA) for State Models for Oral Cancer Prevention and Early Detection-Phase II is to provide funding for the design, implementation and evaluation of interventions based on a needs assessment regarding oral cancer. This needs assessment could have included some or all of the following: (a) an epidemiological assessment of the level of oral cancer within the state; (b) an assessment of the level of knowledge of oral cancer risk factors among health professions and the public; (c) documentation and assessment of practices in diagnosing oral cancers in health professions; and (d) an assessment of whether adults are receiving an oral cancer examination/screening annually from a healthcare provider. Based on the findings from a needs assessment, applicants to this RFA will design, implement and evaluate interventions to raise awareness about oral cancer risk factors and prevention and promote the early detection of oral cancers. An emphasis is placed on a state approach because each state has particular demographics, oral cancer epidemiology and practice acts governing health professions. Also, differences exist among state health departments, state cancer control programs, tobacco control, policies regarding use of tobacco settlement dollars and awareness of oral cancer prevention and early detection by the public and health professionals. The five-year grant is expected to use the organizational infrastructure and the plan of action from the needs assessment to determine the type of interventions require in that state to promote the prevention and early detection of oral and pharyngeal cancers. Some of the interventions may be designed for health care providers. Based on the research literature on dissemination of information to health care providers, printed materials (including journal articles) don't have a strong effect on changing the behavior of health care providers. Behavioral changes are more enduring when addressing regulatory, normative, economic, and peer influences. Examples of regulatory influence include third party reimbursement policies, tobacco control policies, the threat of malpractice and sanctions by peer review or other authoritative bodies. Normative influences refer to those influences during professional training. 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. A combination of strategies and interventions may be more powerful in changing the clinical practice behaviors of well- established, experienced health care providers. Also, interventions designed for the public are essential and they should address the determinants of behaviors such as social norms, attitudes, feelings of self-efficacy, literacy and prior habits. Overall for successful behavioral changes a combination of interventions for both providers and the public is crucial. Examples of interventions appropriate to this initiative include but are not limited to the following: o Providing innovative continuing education courses for providers o Media involvement – presentations in radio or TV programs o Sponsoring an oral cancer awareness week in the state, county or city o Development of educational materials for specific target groups o Partnering with agencies and institutions providing services to individuals at high risk o Inclusion of oral cancer in tobacco cessation programs o Providing educational activities at barber shops or other locations as identified by the needs assessment o Developing campaigns of oral cancer prevention with sport organizations o Developing innovative approaches to integrate the delivery of oral cancer examinations with other preventive services Illustrative examples of the finals outcomes that could be measured by the Phase II interventions may be an increase in the: 1) Number and types of providers doing oral cancer examination/screening, 2) Number of providers that feel confident about providing an oral cancer examination/screening, 3) Number of providers using adjunct procedures for early detection of oral and pharyngeal cancers 4) Increased knowledge of oral cancer risk factors among providers and the public 5) Increased number of providers having an oral cancer continuing education course in the past five years 6) Increased number of providers assessing tobacco use 7) Increased number of providers assessing alcohol use 8) Policy and/or legislation to encourage providers to do an oral cancer examination/screening 9) Increase the number of adults who had an oral cancer examination/screening the past year Other possible outcomes could be: 1) the inclusion of oral cancer in the cancer control program of the state, 2) the development of oral cancer educational materials targeting populations at risk in the state, 3) an increase in time devoted to oral cancer training in medical, dental, dental hygiene, physician assistants, or nursing programs at state and private universities or colleges, and 4) the development of educational interventions among targeted populations. MECHANISM OF SUPPORT This RFA will use NIH Research Project Grant (R01) award mechanism. As 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 30, 2004. Applications that are not funded in the competition described in this RFA may be submitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats. (see http://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. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NIDCR and NCI intend to commit $1,500,000 total costs in FY2004 or FY 2005 to fund 3 new grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $333,000 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 IC(s) provide support for this program, awards pursuant to this RFA are contingent upon availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) R01 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. 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 An eligibility requirement is to have completed a needs assessment for oral cancer in a state. This needs assessment could have included some or all of the following: (a) an epidemiological assessment of the level of oral cancer within the state; (b) an assessment of the level of knowledge of oral cancer risk factors among health professions and the public; (c) document and assess practices in diagnosing oral cancers in health professions; and (d) an assessment of whether or not the public is receiving an oral cancer examination/screening annually from a healthcare provider. The needs assessment may have been funded by the NIDCR or other sources. Grantees will be expected to attend a one-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 the principal investigator and/or one additional investigator. 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 inquiries regarding programmatic issues: 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 4AS43B Bethesda, MD 20892-6401 Telephone:(301) 594-5497 Fax: (301) 480-8319 E-mail: maria.canto@nih.gov Direct inquiries regarding peer review matters 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: Mary Daley Grants Management Branch Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN44B Bethesda, MD 20892-6402 Telephone: 301-594-4808 FAX: 301-480-3562 Email: daleym@mail.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: 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 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is also available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. R01 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 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. 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. 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 an appropriate national advisory council or board. 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 Applications received in response to this RFA will be reviewed by Special Emphasis Panel (SEP) organized by NIDCR or CSR. 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 employ innovative approaches for attaining the aims and objectives? (4) INVESTIGATOR: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the investigator's experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which the 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? PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. 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: November 14, 2003 Application Receipt Date: December 17, 2003 Peer Review Date: January/February 2004 Council Review: May/June 2004 Earliest Anticipated Start Date: September 30, 2004 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 HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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 "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 are 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- 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 http://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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html . PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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. 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 at http://www.cfda.gov/. This program is described in the Catalog of Federal Domestic Assistance Nos. 93.121 (NIDCR) and 93.399 (NCI) 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 http://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 Canto, M. T., and Devesa, S. S. (2002). Oral Oncology 38, 610-617. Canto, M. T., Horowitz, A. M., Goodman, H. S., Watson, M. R., Cohen, L. A., and Fedele, D. J. (1998a). Gerodontology 15, 79-86. Canto, M. T., Kawagushi, Y., and Horowitz, A. M. (1998b). J Public Health Dent 58, 241-7. Chung, V., Horowitz, A. M., Canto, M. T., and Siriphant, P. (2000). Journal of Public Health Dentistry 60, 49-54. Devesa, S. S., Blot, W. J., and Fraumeni, J. F., Jr. (1990). Epidemiology 1, 116-21. DiGuiseppi, C., Atkins, D., and Woolf S.H. (1996). "U.S. Preventive Services Task Force. Guide to clinical preventive services." Williams & Wilkins, Baltimore. Forrest, J. L., Horowitz, A. M., and Shmuely, Y. (2001). J Dent Hyg 75, 271-81. Gillison, M. L., Koch, W. M., and Shah, K. V. (1999). Curr Opin Oncol 11, 191-199. Horowitz, A. M., Drury, T. F., Goodman, H. S., and Yellowitz, J. A. (2000). Journal of the American Dental Association 131, 453-462. Horowitz, A. M., Goodman, H. S., Yellowitz, J. A., and Nourjah, P. A. (1996). J Public Health Dent 56, 319-30. Horowitz, A. M., Moon, H., Goodman, H. S., and Yellowitz, J. A. (1998). J Public health Dent 58, 281-7. Horowitz, A. M., Nourjah, P., and Gift, H. G. (1995). J Am Dent Assoc 126, 39-45. Jemal, A., Thomas, A., Murray, T., and Thun, M. (2002). CA Cancer J Clin 52, 23-47. Myers, J. N., Elkins, T., Roberts, D., and Byers, R. M. (2000). Otolaryngol Head Neck Surg 122, 44-51. Pitman, K. T., Johnson, J. T., Wagner, R. L., and Myers, E. U. (2000). Head & Neck 22. Potter, J. D., Chavez, A., Chen, J., Ferro-Luzzi, A., and Hirohata, T. (1997). World Cancer Research Fund/American Institute of Cancer Research, Washington DC. Ries, L. A. G., Eisner, M. P., Kosary, C. L., Hankey, B. F., Miller, B. A., Clegg, L., and Edwards, B. K. (2002). National Cancer Institute, Bethesda, MD. Ries, L. A. G., Kosary, C. L., Hankey, B. F., Miller, B. A., Clegg, L., and Edwards, B. K. (1999). National Cancer Institute. Silverman, S. J. (2001). JADA 132, 7S-11S. Smith, R. A., Cokkinides, V., von Eschenbach, A. C., Levin, B., Cohen, C., Runowicz, C. D., Sener, S., Saslow, D., and Eyre, H. J. (2002). CA Cancer J Clin 52, 8-22. Wynder, E. L., Mushinski, M. H., and Spivak, J. C. (1977). Cancer 40, 1872-8. Yellowitz, J. A., Horowitz, A. M., Drury, T. F., and Goodman, H. S. (2000). JADA 131, 653-61. Yu MC, H. B. (1996). In "Cancer Epidemiology and Prevention" (F. J. Schottenfeld D, ed.), pp. 603-618. Oxford University Press, New York. Zhang, Z., Morgenstern, H., Spitz, M., Tashkin, D., Yu, G., Marshal, J., Hsu, T., and Schantz, S. (1999). Cancer Epidemiology, Biomarkers & Prevention 8, 1071-1078.

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