RFA-DE-00-005: STATE MODELS FOR ORAL CANCER PREVENTION AND EARLY DETECTION

Department of Health
and Human Services (HHS)

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STATE MODELS FOR ORAL CANCER PREVENTION AND EARLY DETECTION Release Date: June 22, 2000 RFA: DE-00-005 National Institute of Dental and Craniofacial Research (http://www.nidcr.nih.gov/) National Cancer Institute (http://www.nci.nih.gov/) Letter of Intent Receipt Date: December 15, 2000 Application Receipt Date: February 16, 2001 THIS RFA USES THE MODULAR GRANT AND JUST-IN-TIME CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APLICATIONS IN RESPONSE TO THIS RFA PURPOSE The National Institute of Dental and Craniofacial Research (NIDCR) and the National Cancer Institute (NCI) invite applications from eligible institutions for grants to aid in research leading to the development of state models for oral cancer prevention and early detection programs. This initiative is viewed as a first step in the use of oral health assessments as part of an evaluation of overall systemic health. The aims of the current initiative are to: (a) support an epidemiological assessment of the level of oral cancer within the state, (b) assess level of knowledge of oral cancer risk factors among health professions (e.g., dentistry, medicine, pharmacy, nursing, dental hygiene, physician assistants and health educators) and the public, (c) document and assess practices in diagnosing oral cancers in health professions, and (d) assess whether or not the public is receiving an oral cancer examination annually from a healthcare provider. A statewide assessment, as opposed to any other approach, is key 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, policies regarding use of tobacco settlement dollars and awareness of oral cancer prevention and early detection by the public and health professionals. The three-year grant is expected to be used in leading to the development of an organizational infrastructure and a plan of action necessary for designing and implementing future interventions to prevent and reduce oral cancer morbidity and mortality. It is the intention of the NIDCR and the NCI to issue a subsequent Request for Application (RFA) to support the development, implementation and evaluation of interventions promoting oral cancer awareness, prevention and early detection. Specific response to this RFA will require information obtained during the three-year developmental period. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010 , a PHS- led national activity for setting priority areas. This Request for Application (RFA), State Models for Oral Cancer Prevention and Early Detection, is related to three or more of the priority areas. Potential applicants may obtain more information about 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, such as colleges, universities, units of state and local governments and eligible agencies of the federal government. Foreign organizations are not eligible and domestic organizations may not include international components. Collaborative applications among eligible domestic organizations are encouraged. Among collaborators, one must be designated as the lead applicant and assume administrative and scientific responsibility for the project. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators (PI). MECHANISM OF SUPPORT The mechanism of support utilized will be an Exploratory/Developmental Grant (R21). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant and collaborating institutions. However, consultation with NIDCR and/or NCI staff will be expected and a meeting with the principal investigator, key personal and NIDCR and NCI staff will be scheduled each year after initial funding. The total project period may not exceed three years. This RFA is a one-time solicitation, and grants funded through it may not be renewed or extended. The earliest possible date for funding of the R21 applications is July 2001. It is anticipated that a second RFA will be issued in 2003 for competition among those institutions receiving support as part of the current RFA as well as states that have completed Phase I using funds provided by other sources. Depending on the availability of funds and scientifically meritorious applications, we plan to fund up to 10 of the Phase II applications. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" application procedures. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm and in the NIH Guide for Grants and Contracts, December 15, 1998 (http://grants.nih.gov/grants/guide/notice-files/not98-178.html). FUNDS AVAILABLE It is expected that up to $2.0 million per year will be allocated in support of the developmental grants. The NIDCR and NCI plan to fund up to 13 grants, providing sufficient numbers of highly scientifically meritorious applications are received and provided that sufficient funds are available. Each request may not exceed $100,000 direct costs for each of the three- years. All applications must include costs for travel to one meeting per year in Bethesda for the principal investigator and key personnel. Applicants are reminded that that other sources of funding maybe available to augment these activities. RESEARCH OBJECTIVES Dental and craniofacial diseases and disorders are among the most common health problems affecting the people of the United States. The burden imposed by a variety of dental and craniofacial diseases and disorders range from birth defects such as cleft lip and palate, which occurs in every 1 in 525 to 714 live births, to injuries to the head and face, resulting in nearly 20 million emergency room visits per year, to devastating head and neck cancers of which oral and pharyngeal cancers account for 8,000 deaths per year and more than 30,000 new cases per year. The treatment of over 1.2 million cancer patients each year can lead to complications such as painful mouth ulcers, mucositis, rampant dental caries, fungal infections, impaired taste and loss of function of the salivary glands. Oral infections still remain common in our populations. Dental caries is experienced by 45% of elementary aged school children and 94% of adults have experienced this infection at some point in life. Periodontal infections occur in 90% of individuals older than 13 years and may be associated with other systemic diseases or conditions such as diabetes, cardiovascular disease, respiratory infections, and pre-term/low birth weight babies. Orofacial pain is likely to have been experienced by over 20% of adults in the past six months, is a major component of temporomandibular joint diseases (TMD) for at least 6% of adults, and is a major component of Bell"s palsy, trigeminal neuralgia and fibromyalgia. Salivary gland dysfunction in the form of Sjogren’s syndrome affects between 1 and 4 million Americans while over 30,000 individuals who have cystic fibrosis are also at higher risk for concomitant salivary gland dysfunction. Further, over 500 prescription drugs have xerostomic (dry mouth) side effects, increasing the risk for both bacterial and fungal oral infections as well as other oral conditions. Oral candidiasis is commonly found in HIV-infected patients. From a public health perspective, it is not only important to understand the etiology, pathogenesis, treatment and prevention of oral diseases and conditions per se but it is also clear that such an understanding can play a central role in the understanding, treatment and prevention of other systemic diseases and conditions and vice versa. On the one hand, oral assessments can provide convenient and important biomarkers for systemic disease as well as information about the oral health status of the individual. Further, in order to develop an understanding of overall health and/or disease it is imperative to understand oral health and/or diseases since without oral health the individual cannot be considered to be healthy. While the present initiative addresses one aspect of this global approach to understanding health and disease, it is consistent with this initiative to view oral assessment as integral to a broader understanding of health and disease. Our interest here is in the early detection and identification of oral and pharyngeal cancer (i.e., cancers of the oral cavity and pharynx). While our focus is on these aspects of the anatomy, it would also be appropriate to include within the scope of this initiative head and neck cancers as long as they also included oral and pharyngeal cancers. Background In 1999 it was estimated that oral and pharyngeal cancers would account for 29,800 cases and 8,100 deaths in the United States (Landis, Murray et al. 1999). More than 90% of oral cancers occur in individuals 45 years of age and over (Ries, Kosary et al. 1999). 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, Goodman et al., 1996, Ries, Kosary et al. 1999). The age-adjusted incidence rate for total oral cavity and pharynx cancers was 10.0 per 100,000 population in 1996 (Ries, Kosary et al. 1999). While these cancers represent 3% of all cancers in the United States they have one of the lowest five-year survival rates of any of the major cancer sites. Their overall five-year survival rate is 53% and it has not changed in the past thirty years (Swango 1996). These low survival rates may be attributed to the fact that these cancers tend to be diagnosed at advanced stages. Moreover, these cancers and the regimen utilized for their treatment are extremely disfiguring and often result in severe loss of function including inability to swallow and impairment of speech. The major risk factors for oral cancers in the United States are use of tobacco and alcohol. The use of these two products account for 75% of all oral cancers (Wynder, Mushinski et al. 1977). A recent case-control study suggests that marijuana use may increase the risk for head and neck cancer (Zhang, Morgenstern et al. 1999). 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 (Horowitz, Goodman et al. 1996, Devesa, Blot et. al. 1990). Other risk factors include exposure to viruses such as human papillomavirus (Gillison, Koch et al. 1999) and Epstein-Barr virus (Yu MC 1996). An increased consumption of fruits and vegetables is associated with lower risk of oral cancers (Potter, Chavez 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 and sunlight. A visual and tactile examination of the oral cavity is essential for early detection. Because of the significant morbidity and mortality associated with the diagnosis of oral cancer at advance 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 (Update January 1992, Horowitz, Goodman et al. 1996). The U.S. Prevention Services Task Force recommends that clinicians include a careful examination for oral cancer in asymptomatic individuals who use tobacco or alcohol (DiGuiseppi, Atkins 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, other health care providers (i.e., nurse practitioners, physician assistants, physicians) should 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 (Yellowitz JA, Horowitz AM, Drury TF, Goodman HS, A survey of US dentists knowledge and opinions about oral cancer, in press). 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, nor to palpate lymph nodes (Abstract, APHA meeting, Chicago, November, 1999). These national surveys also addressed the age group of patients receiving an oral cancer examination 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 for edentulous patients 18 years of age or older and 81% provided an oral cancer examination to all their patients above 40 years of age in the initial appointment (Horowitz AM, Drury TF, Goodman HS, Yellowitz JA, Dentists practices and opinions regarding oral cancer prevention and early detection, in press). 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 and 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 (Abstract AAPHA, San Francisco, October, 1998). 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. 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 7% in the past year. Lack of adequate knowledge by the general public (Horowitz, Nourjah et al. 1995) and veterans receiving services at the VA Maryland Health Care System (Canto, Horowitz et al. 1998) was partially explained by minimal coverage of oral cancers in popular magazines and newspapers, (Canto, Kawagushi et al. 1998) and limited availability of oral cancer educational materials designed for the public (Abstract IADR/AADR, Vancouver, Canada, March 1999). Oral cancer awareness 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 most effectively provide oral cancer examinations. 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. Project Design The overall project must include a sound-planning framework embodying state- of-the-science planning principles, approaches, and sequencing of program activities (including needs assessment, program design and initiation, implementation, evaluation, and sustainability). The total project will consist of two phases: Phase I, the establishment of an organizational infrastructure and needs assessment to be funded for three years, Phase II, the development and pilot testing of educational interventions, and program evaluation to be funded for five years. It is the intent of the current RFA to support Phase I activities, which includes planning and development of an organizational infrastructure as well as the state needs assessment regarding oral cancer prevention and early detection. The state needs assessment will consist of: (a) a review of epidemiological data (incidence, prevalence, mortality) of oral cancer, (b) a review of available resources for cancer prevention and control, (c) an assessment of cancer diagnosis by the various health professionals (i.e., frequency with which each profession diagnoses oral cancers as well as the stage at which oral cancers are diagnosed), (d) a qualitative and quantitative assessment of health care provider’s and the general public’s oral cancer knowledge, opinions and practices about oral cancer prevention and early detection, and (e) an evaluation of the types of educational materials available to the public and health professionals in the state on oral cancers. The organizational infrastructure envisioned is a statewide partnership among groups and/or agencies interested in oral cancer prevention and early detection. Members of the partnership shall include, at a minimum, the State Health Officer and/or Dental Director and an academic institution (i.e., universities with medical, dental, nursing or public health schools). Additional groups could include, but are not limited to, federal, state, and local governments, other schools and universities, religious organizations, consumer organization, businesses, child and youth agencies, American Cancer Society, and/or health care provider associations. The partnership must identify a lead group or agency that would serve as the grantee institution, a leadership structure and operating procedures. It is strongly recommended that an academic institution be the grantee institution. A major aim of Phase I is the establishment of the partnership for oral cancer prevention in the state, which will direct the development and implementation of future activities well beyond the scope of this or subsequent RFAs. A member of an academic institution should be identified as Research Director and be responsible for research activities such as collection and analysis of epidemiological data, and the development and administration of surveys. The Research Director also may be the application’s principal investigator if s/he is located at the grantee institution. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research , which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent no later than December 15, 2000 that includes a descriptive title of the proposed research, the name, address, email address if available and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application is submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDCR and NCI staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent to Dr. Norman S. Braveman, the NIDCR program staff listed under INQUIRIES. INFORMATIONAL CONFERENCE An informational conference will be held on September 29, 2000 in Building 31, Room 6C6, National Institutes of Health, Bethesda, Maryland from 8:30 a.m. until 5 p.m. No pre-registration is necessary but it would be helpful to indicate your intention to attend by contacting Dr. Norman Braveman. Contact information is listed under the section titled INQUIRIES. The conference will address the scientific and administrative issues associated with this RFA. Representatives from the NIDCR and the NCI will be available to provide information and to answer questions from potential applicants responding to this RFA. Materials presented at the conference will be available for those unable to attend. APPLICATION PROCEDURES The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form, PHS 398 (revised 4/98) is to be used in applying for these grants, with the modifications noted below. 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. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total of $100,000 direct costs for each of three-years. The modular budget request must be in accordance with the modifications made to the standard PHS 398 application instructions described below: PHS 398 FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. NARRATIVE BUDGET JUSTIFICATION Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages). At the top of the page, enter the total direct costs requested for each year. This is not a Form page. UNDER PERSONNEL List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include a Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. BIOGRAPHICAL SKETCH The biographical Sketch provides information used by reviewers in the assessment of each individual’s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position (s) and any honors, - Provide information including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. CHECKLIST This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The application should provide the name and phone number if the individuals to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 (DE-00-005) must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typed written 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 (2) additional copies of the application must also be sent to: Dr. H. George Hausch Scientific Review Branch Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-38D, MSC 6402 Building, Room Number, MSC 6402 Bethesda, MD 20892-6402 Applications must be received by February 16, 2001. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and for responsiveness by NIDCR and NCI staff. Incomplete and/or non-responsive applications will be returned to applicants without further considerations. 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 and the National Cancer Advisory 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 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, investigators may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Listed below are the review criteria to be used in the evaluation of the applications: Significance: Does the project address geographical areas that exhibit an oral cancer burden? If aims of the project are accomplished, how will scientific knowledge be advanced? What will be the effect of the project on oral cancer prevention and early detection? Approach: Are the conceptual framework, design methods and analyses adequately developed, well integrated and appropriate to the aims of the project? Does the investigator acknowledge potential problems and consider alternative approaches? Does the approach provide a sound-planning framework? Is there a plan for developing the organizational infrastructure (partnership) for oral cancer prevention and early detection? Is there an appropriate plan for collection and analysis of epidemiological data? Does it address relevant recommendations from the National Strategic Conference for the Prevention and Control of Oral and Pharyngeal Cancer held on August 7-9, 1996? Is the proposed partnership likely to obtain and effectively utilize leveraged funding, such as tobacco settlement funds directed towards the reduction of oral cancer through tobacco cessation? Innovation: Does the project employ novel concepts, approaches or methods? Investigator: Is the investigator appropriately trained and well suited to carry out the work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any) associated with the project? Has the investigator published in this area of research? Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed project take advantage of unique features of the scientific environment or employ useful collaborative arrangements (including community involvement)? Is there evidence of institutional support? Are letters of support from organizations interested in being part of the partnership included? Are resources available to perform the needs assessment? INQUIRIES Written, e-mail, and telephone inquires concerning this RFA are encouraged particularly early in the application development process. The opportunity to clarify any issues or questions from potential applicants is welcome. All inquiries should be directed to one of the NIH staff listed below: Scientific and Administrative Issues: Dr. Norman S. Braveman Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-24A, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8318 Email: Norman.Braveman@nih.gov Cathy L. Backinger, MPH, PhD Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Blvd, EPN 4044 Rockville, MD 20852 Telephone: (301) 496-8584 FAX: (301) 496-8675 Email: cb270r@nih.gov Dr. Alice M. Horowitz Office of Science Policy and Analysis 45 Center Drive, Room 3AN-44, MSC 6401 Bethesda, MD 20892-6401 Telephone: (301) 594-5391 FAX: (301) 435-8667 Email: Alice.Horowitz@nih.gov Direct inquiries regarding fiscal matters to: Mr. Martin R. Rubinstein Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44A, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 Email: Martin.Rubinstein@nih.gov Schedule Informational Conference: September 29, 2000 Letter of Intent Receipt Date: December 15, 2000 Application Receipt Date: February 16, 2001 Peer Review Date: April, 2001 Council Review: June, 2001 Earliest Possible Funding: July 2001 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93. 121. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 41 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92. This program is not subject to intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES Canto, M. T., A. M. Horowitz, et al. (1998). Maryland veterans" knowledge of risk factors for and signs of oral cancers and their use of dental services. Gerodontology 15(2): 79-86. Canto, M. T., Y. Kawagushi, et al. (1998). Coverage and quality of oral cancer information in the popular press:1987-98. J Public Health Dent 58(3): 241-7. Devesa, S. S., W. J. Blot, et al. (1990). Cohort trends in mortality from oral, esophageal, and laryngeal cancers in the United States [see comments]. Epidemiology 1(2): 116-21. DiGuiseppi, C., D. Atkins, et al. (1996). U.S. Preventive Services Task Force. Guide to clinical preventive services. Baltimore, Williams & Wilkins. Gillison, M. L., W. M. Koch, et al. (1999). Human papillomavirus in head and neck squamous cell carcinoma: are some head and neck cancers a sexually transmitted disease? Curr Opin Oncol 11: 191-199. Horowitz, A. M., H. S. Goodman, et al. (1996). The need for health promotion in oral cancer prevention and early detection. J Public Health Dent 56(6): 319-30. Horowitz, A. M., P. Nourjah, et al. (1995). US adult knowledge of risk factors for and signs of oral cancers: 1990. J Am Dent Assoc 126: 39-45. Landis, S. H., T. Murray, et al. (1999). Cancer statistics, 1999. CA Cancer J Clin 49(1): 8-31, 1. Potter, J. D., A. Chavez, et al. (1997). Food, nutrition and the prevention of cancer: a global perspective. Washington DC, World Cancer Research Fund/American Institute of Cancer Research. Ries, L. A. G., C. L. Kosary, et al. (1999). SEER Cancer Statistics Review, 1973-1996, National Cancer Institute. Swango, P. A. (1996). Cancer of the oral cavity and pharynx in the United States: an epidemilogic overview. J Public Health Dent 56(6): 309-318. Update January 1992: the American Cancer Society guidelines for cancer- related check-up.(1992). CA-Cancer J Clin 42: 44-45. Wynder, E. L., M. H. Mushinski, et al. (1977). Tobacco and alcohol consumption in relation to the development of multiple primary cancers. Cancer 40(4 Suppl): 1872-8. Yu MC, H. B. (1996). Nasopharyngeal Cancer. Cancer Epidemiology and Prevention. F. J. Schottenfeld D. New York, Oxford University Press: 603-618. Zhang, Z., H. Morgenstern, et al. (1999). Marijuana Use and Increased Risk of Squamous Cell Carcinoma of the Head and Neck. Cancer Epidemiology, Biomarkers & Prevention 8: 1071-1078.

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