Full Text CA-92-17 5-A-DAY FOR BETTER HEALTH NIH GUIDE, Volume 21, Number 12, March 27, 1992 RFA: CA-92-17 P.T. 34 Keywords: Nutrition/Dietetics Cancer/Carcinogenesis Behavioral/Social Studies/Service Statistics National Cancer Institute Letter of Intent Receipt Date: April 24, 1992 Application Receipt Date: June 9, 1992 PURPOSE The Division of Cancer Prevention and Control of the National Cancer Institute (NCI) invites applications for grants to develop, implement, and evaluate interventions in specific community channels and/or for specific target populations to increase the consumption of fruits and vegetables, using the 5-A-Day message. The 5-A-Day message is "Eat 5 servings of fruits and vegetables a day for better health." (Products promotable through the program and serving sizes are defined in Appendix A, available from the NCI program contact listed under INQUIRIES.) Fruits and vegetables are promoted in the program in a manner that retains their integrity as low-fat foods and as part of an overall healthy eating pattern that is low in fat and high in fiber. A channel is defined for this application as a specific means or route for reaching consumers with messages and/or food for the purpose of creating the desired dietary behavior change. Examples are schools, food service (may include restaurants and cafeterias) worksites, and food assistance programs. Within the channel, a target population must be selected. For example, if schools are selected as the channel, all students may be targeted or students in specific grades may be targeted. Wherever it seems appropriate, applicants will be expected to utilize the mass media as a part of the intervention. In addition, complementary partnerships with the fruit and vegetable industry are encouraged. The intent of the announcement is two-fold: (1) to encourage research in the development of effective community level interventions for changing dietary patterns using a simple, positive, actionable message; and (2) to develop the community-level component of the national 5-A- Day program, providing the complementary and necessary interactive and environmental elements of successful behavioral change interventions, such as the development of skills, local media placement, social support, and modifications of foods offered in local food systems. These community interventions are an important component of the larger national program, that will provide national media coverage and industry-initiated activities. The national program is a partnership between the fruit and vegetable industry and the NCI, discussed in the section below entitled "Background." HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, 5-A- Day for Better Health, is related to the priority area of nutrition, specifically objective 2.6. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as units of state and local governments, universities, colleges, hospitals, research institutions, consultant firms, or combinations thereof. Universities, colleges, research institutions, hospitals, and consultant firms must involve either a public health agency or some other public agency with a mandate to protect public health and the ability to access and intervene appropriately in the channel or community chosen. All applications will be expected to incorporate appropriate research design and analysis expertise, most frequently provided by universities, colleges, research institutions, and consultants. Interdisciplinary teams of applicants are encouraged. Among a team of applicants, one institution must be proposed as the lead institution. Foreign applicants are not eligible. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this program will be through the NIH individual grant mechanism (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. However, it is anticipated that a network of grantees will be formed for the purposes of sharing design and evaluation strategies, comparing results when possible, and distilling lessons learned from all grants combined. (See SPECIAL REQUIREMENTS section.) The total project period for applications submitted in response to the present RFA may not exceed four years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The NCI anticipates that $4,000,000 in total costs per year for four years will be available for this RFA. Up to 10 awards are planned. This funding level is contingent upon receipt of a sufficient number of applications of high scientific merit and the availability of funds. The total project period for each award will be up to four years. Applicants should determine what resources are required to achieve their scientific objectives and budget accordingly. RESEARCH OBJECTIVES It is the goal of this research to develop, implement, and evaluate interventions that use the 5-A-Day message in specific community channels and/or for specific target populations to increase the consumption of fruits and vegetables. The primary objectives of this research are: (1) To increase awareness in the target population of the importance of eating at least five servings of fruits and vegetables every day for better health. (2) In channels chosen, where appropriate, to increase the supportiveness of the environment for increased fruit and vegetable consumption, either through increasing the offering of foods that meet the criteria for the 5-A-Day program, policy changes, or other structural or educational changes that would promote fruit and vegetable consumption. (Criteria are listed in Appendix A.) (3) To increase the daily consumption of fruits and vegetables in the target population significantly more than in the control population. Proposals should address one of the following two design options. Designs other than those described below are allowed but will require justification: (1) Interventions focused on a specific channel: The major research question to be answered is: Will the target groups (e.g., schools, worksites) in a specific channel that receive a 5-A-Day intervention, based on a selected model of dietary behavior change, demonstrate a significantly greater increase in fruit and vegetable consumption than the groups in the same channel not receiving the intervention? (A group is most likely to be the unit of randomization. See the section on sample size considerations.) Other research questions of interest are: Will the target groups in a specific channel that receive a 5-A-Day intervention demonstrate greater changes in dietary awareness, knowledge, attitudes and behavior than the control groups? Will the organizations or entities in a specific channel that receive a 5-A-Day intervention (e.g., schools, school cafeterias; worksites, worksite cafeterias) demonstrate greater environmental support for increased fruit and vegetable consumption than the organizations or entities in the same channel not receiving the intervention? Other innovative research questions are invited. (2) Interventions focused on a specific hard-to-reach population: The major research question to be answered is: Will the groups in a specific hard-to-reach population receiving a 5-A-Day intervention, based on a selected model of behavior change, demonstrate a significantly greater increase in fruit and vegetable consumption than groups in the same target population, not receiving the intervention? Choice of a single channel is preferable for this research question. However, more than one channel may be used with adequate justification of why these specific channels are more appropriate for reaching the target population than a single channel. Examples of appropriate target populations might be ethnic groups, such as Blacks, Hispanics, or Asians; low income groups; low literacy groups, and other groups at high risk. Other research questions of interest are the same as those enumerated in design option (1) above, applied to the hard to reach target population. Other innovative research questions are invited. Interventions should be based on a sound rationale that demonstrates an understanding of human behavioral science, the particular channel, geographic areas, and target populations chosen. It is highly recommended that geographic areas chosen be of a size that is manageable by the resources requested and yet include adequate numbers for attaining statistical significance. Interventions should be based on a model of behavioral change, reflective of current theories and research, and should demonstrate a knowledge of how to create awareness, motivation, support, and sustained lifestyle changes for individuals and how to create lasting changes in food systems and organizations that will support the requisite individual dietary changes. The grant application should include a rigorous evaluation, including appropriate outcome and process measures. Interventions should be transferable to the same channels in other settings. Applicants should provide a rationale for their choice of target populations and channel of intervention. A model of behavioral change should be used to guide the intervention, integrating constructs from appropriate theories such as, but not limited to, social marketing, social cognitive theory, health belief model, stages of change, and diffusion of innovations. (See Glanz et al., eds., 1990.) Strategies for determining the appropriate system/organizational changes within a channel should be identified, including targeting the appropriate entities, organizations, or individuals within the channel. Methods for determining the appropriate messages and strategies for reaching the target group, including understanding the consumers' wants and needs, should be identified. The evaluation plan should include both process and outcome measures, with appropriate instruments for measuring individual and organizational changes. Appropriate measures of dietary consumption in a community setting, especially for measuring change, is a much debated issue. For purposes of this RFA, appropriate instruments to use might include, but are not limited to, the 24-hour recall, the food frequency, food records, or a shorter instrument that has been tested for validity and reliability. The instrument(s) chosen must be justified as an appropriate and feasible means of measuring outcomes. One of the implications of a broad, national 5-A-Day program for research designs is that some contamination of control sites is likely to occur. Therefore, it is important to construct powerful interventions with enough intensity and penetration to measurably exceed the national trends and to develop creative ways of tracking activities in control and intervention sites. Another implication of the national program is that various industry participants, such as supermarkets, will be licensed to use 5-A-Day materials. Whenever feasible, applicants are encouraged to work cooperatively with industry partners in the target areas chosen. A list of current industry participants may be found in Appendix B which may be obtained from the NCI program contact listed under INQUIRIES. The power to detect the desired behavioral changes will determine the number of intervention units required. Randomization of units to intervention and control conditions is the preferred design, although other well-justified designs will be considered. Some suggested sample size considerations are in Appendix C, which is available from the contact listed in INQUIRIES. Background As a part of the capacity-building grants for state health departments, the National Cancer Institute supported a 5-A-Day statewide initiative in California to increase vegetable and fruit consumption among consumers. The "5-A-Day" message, developed by the California State Health Department working with a board of industry representatives, received widespread media exposure. Between 1988 and 1991, the message was promoted by 16 supermarket chains, representing more than 1,850 stores, at their own expense. In the three years of the campaign, over 225 media interviews occurred, resulting in about 70 million media exposures. The dollar value of industry and mass media contributions was estimated at over $1.5 million. The campaign, with its simple, actionable message, created enthusiastic support among produce growers, retailers, and commodity boards. The State of California, numerous national industry organizations, and health departments indicated strong interest in expanding the 5-A-Day concept to the national level. The major partners in this new national effort are the National Cancer Institute and the Produce for Better Health Foundation (PBH). PBH is a non-profit foundation formed in May, 1991, for the purpose of working with NCI on this national promotion of fruit and vegetable consumption. PBH consists of 76 companies representing producers, suppliers, merchandisers, commodity boards, growers, shippers, supermarkets, and manufacturers. The PBH Foundation is licensed by the NCI to use the 5- A-Day logo and materials, which are trademarked. The Foundation in turn sublicenses other partners, such as supermarkets, to participate in the national program. As of February, 1992, more than 80 retailers had signed license agreements, representing more than 25,000 supermarket chain and independent grocery stores. In addition, more than 50 merchandisers were licensed. (See Appendix B.) Licensees must abide by the guidelines for use of the materials, logo and the NCI name, as outlined in Appendix A, available from the program contact listed under INQUIRIES. The program will expand over time to include other licensees such as grantees from this RFA, health agencies, and food service participants. The major components of the national 5-A-Day program are the national supermarket intervention, a national media campaign, and the community intervention component which will be developed in response to this RFA. The national supermarket intervention consists of printer-ready copies of brochures, recipes, and store signage provided to supermarkets at least two times per year by the national program. Each participating supermarket agrees to run at least two promotions per year, consisting of one month duration for each promotion. Interactive events in supermarkets are encouraged. Supermarkets must report process measures to the national campaign on a periodic basis. Any synergy with the components of the campaign (such as the supermarket intervention) that will contribute to the research outcomes desired by this RFA are encouraged. For example, it might be appropriate for grantees to assist with interactive events in supermarkets at the local level; alternatively supermarkets may be able to assist with interventions in another community channel. The national media campaign consists of a plan developed by the Office of Cancer Communications at NCI and a complementary plan developed by the fruit and vegetable industry. The major components of the media campaign are two media waves per year for print and broadcast media, the utilization of national spokespersons, use of the Cancer Information Service national hotline, and press conferences coordinated with the national supermarket promotions. Grantees should work as much as possible in tandem with the national media waves to develop complementary local media placements, where appropriate. Specific timing of national media events is not yet determined for 1993. The successful respondents to this RFA will constitute the community level intervention component of the national program. In addition, national, state, or local health, education, voluntary or agricultural agencies may request to be licensed to participate at their own expense in the national effort. Scientific Rationale In a review of 12 case control and cohort studies, Willett (1990) stated that "the inverse relationship between the intake of vegetables and fruits and the risk of lung cancer represents one of the best established associations in the field of nutritional epidemiology." In a review of 15 prospective and 11 retrospective studies, Ziegler (1991) found the evidence for a protective effect of fruit and vegetable consumption was most persuasive for lung cancer but was also evident for cancers of the mouth, pharynx, larynx, esophagus, stomach, colon, rectum, bladder, and cervix. Of 115 studies reviewed by Block and colleagues (submitted), 81 percent (93 studies) reported a statistically significant protective effect of fruit and vegetable consumption. Persons in the lowest quartile of fruit and vegetable intake (one or fewer daily servings) experience about twice the risk of cancer compared with those in the highest quartile (four or more servings). Recent dietary guidelines published by USDA/DHHS and the National Academy of Sciences (NAS) all recommend that Americans eat at least five or more servings of fruit and vegetables per day (USDA/DHHS, 1990; NRC, 1989). This is consistent with NCI recommendations that stress increased consumption of fruits, vegetables and fiber and reduced fat intake (NCI, 1986; Butrum et al., 1988). This is also consistent with the national objectives enumerated in "Healthy People 2000" (USDHHS, 1990) and the NAS report on implementing dietary guidelines (IOM, 1991). Unfortunately, most Americans fall far short of these recommendations. Only 9 percent of the population ate five or more servings of fruits and vegetables on any given day as reported in NHANES II data (Patterson et al., 1990). Ten percent of U.S. adults had no fruits, fruit juice or vegetables on any given day. More recent data from USDA's Continuing Survey of Food Intakes by Individuals (CSFII) do not indicate any improvement in these numbers (USDA, 1987; Patterson and Block, 1991). Consumption patterns were the poorest among low income women. Over 4 non-consecutive days, 31 percent of the women in the lowest income bracket (less than 131 percent of the poverty level) had no fruit, whereas only 12 percent of the high income women had no fruit. Similar patterns were observed for vegetables (Patterson and Block, 1991). In a 1989 California statewide survey, 34 percent of adults ate five or more total servings of fruits and vegetables on the previous day. Only 23 percent of the California population was aware that they should eat five or more servings a day for good health. Individuals who said they should eat five or more servings ate significantly more fruits and vegetables than those who said they should eat fewer or did not know how many servings they should eat. Thirty-five percent of white Californians and 54 percent of Hispanic Californians did not believe that what they ate had any effect on cancer risk (California Department of Health Services, 1992). Various studies have shown that the media plays a vital role in increasing consumer awareness of health issues and, in some instances, even changing individual patterns of behavior (Levy, 1987; Davis, 1988; Russo, 1986). Public confidence in messages from a credible health agency such as NCI has been shown to be a key factor in affecting consumer buying patterns (Hammond, 1986). The combination of credible health messages promoted through industry via media have been shown to be effective in influencing consumers (Levy, 1987). Sales of high-fiber cereals rose dramatically after a national advertising campaign by the cereal industry which utilized government-approved health information. Hammond's study also found that an individual's stated behavioral intentions seem to be affected by the perception of the credibility of the information source. Thus in the high fiber cereal campaign, public confidence in NCI was a key factor in changing consumer buying patterns. Data suggest that while the public is concerned about diet and health, there is a lack of the detailed knowledge needed to act effectively on these concerns (Levy, 1988). Although use of the media alone can produce behavioral change, its effect is increased when its use is supplemented by other community based educational efforts (Flay, 1987; Farquhar et al., 1977; Puska et al., 1985). These efforts can build on the awareness created by the media to provide skills necessary for people to make lifestyle changes. Research has demonstrated the effectiveness of community-based health education for disease risk reduction and prevention. The Stanford Three-Community Study was successful in reducing the coronary risk factors of people in two communities when compared with a control community (Farquhar et al, 1977). It demonstrated that the health of a community could be improved by an educational message delivered through the media and interpersonal channels. Favorable changes in dietary practices were brought about by mass media campaigns after about 2.5 years (Stern et al, 1976). Changes were produced even more rapidly when personal counseling and intensive instruction were combined with mass media. The North Karelia Project in Finland was able to demonstrate decreases in cardiovascular mortality and morbidity as well as risk factor reduction through a comprehensive community health promotion program which included public education strategies (Puska et al, 1983). The North Karelia Project and the Stanford Three-Community Study both made extensive use of media. The Pawtucket Heart Health Program, which reached blue collar consumers through successful social marketing strategies, was able to attract low literacy populations through simple, specific messages. Simplicity of message has been shown to be a key factor in successful mass media campaigns (Wallack, 1981). The Stanford Five-City Project, which tested whether or not community-wide health education can reduce stroke and coronary heart disease, showed significant net reductions in community risk factor averages in the treatment cities. The risk factor changes resulted in important decreases in composite total mortality risk scores and coronary heart disease risk scores. (Farquhar et al., 1990). The treatment cities received a 5-year, low-cost (about $4/per person/year), comprehensive program based on community organization principles and social marketing methods, including use of mass media. Total exposure to educational messages of various types and duration was calculated to be 100 messages per year, totalling 5 hours per capita. Yearly radio and television exposure was less than 1 hour per adult per year. Researchers concluded that such low-cost programs can have an impact on risk factors in broad population groups. Community-wide studies such as those enumerated above have demonstrated the effectiveness of a mix of interventions, but have not tested the independent effects of channel-specific interventions. The development of such tested channel and target population-specific interventions will be a contribution to research in community nutrition interventions and will assist in meeting the "Healthy People 2000" objectives for the Nation. SPECIAL REQUIREMENTS As stated in the MECHANISM OF SUPPORT section, networking among investigators will be expected. Thus, applications should include in the budget enough funds for at least two investigators to attend two meetings per year in the Washington DC area with fellow grantees. Investigators will be expected to supply a final report in a specific format that summarizes both successes and failures in order to contribute to the dissemination of community intervention research. In addition, grantees will be expected to participate in a joint summary of results of all grants. Grantees will be licensed to use the 5-A-Day logo. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. (See page 21 of PHS 398.) The composition of and the rationale for the choice of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in Sections 1-4 of the Research Plan in the form PHS 398 (rev. 9/91). Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of U.S. racial/ethnic minority populations, (i.e., Native Americans, [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided, and may include the requirements of the RFA, a need for special focus on the target group in order to advance research, etc. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the applications, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by April 24, 1992, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which an application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Jerianne Heimendinger, Sc.D., M.P.H., R.D. National Cancer Institute Division of Cancer Prevention and Control Executive Plaza North, Room 330 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-8520 FAX: (301) 402-0816 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7441; and from the NCI program administrator named below. The RFA label available in the PHS 398 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 must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies in one package to: DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 At the time of the submission, two additional copies of the application must also be sent to: Jerianne Heimendinger, Sc.D., M.P.H., R.D. National Cancer Institute Division of Cancer Prevention and Control Executive Plaza North, Room 330 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-8520 Applications must be received by close of business, June 9, 1992. If the application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG 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 by NCI staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NCI peer review group on the basis of relative competitiveness. The NCI will remove from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NCI. The second level of review will be provided by the National Cancer Advisory Board. Scientific/technical merit criteria specific to the objectives of this RFA include the following: o Extent to which the proposed research will meet the project goal of developing, implementing, and evaluating interventions in specific community channels and/or specific target populations to increase the consumption of fruits and vegetables, using the 5-A-Day message. o Scientific merit of the research design and methodology, including choice of units of analysis; appropriateness of research design; appropriateness of proposed evaluative methods, instruments and analytic techniques; adequacy of methods for monitoring national trends/relevant promotion activities across study sites; and adequacy of data management and quality control procedures. o Merit and feasibility of the planned intervention strategies, including justification for target channels and populations chosen, appropriateness of the behavioral model chosen to guide the intervention; methods for achieving both individual and environmental/organizational (food system) behavioral change. o Documented support for the project from the entities in the channel chosen as well as from other participating entities. o Research experience, intervention experience, and competence of the Principal Investigator and staff and adequacy of time (effort) devoted to the project by appropriate personnel. o Availability of adequate resources to conduct the proposed interventions and evaluations, including personnel with the appropriate skills, equipment, and data processing capacity. o Feasibility of approach to the work, including how tasks are to be carried out by different partners in the project, project management, and stated anticipated problems and proposed solutions. o Extent to which relationships have been or will be developed between universities and public agencies or other sources of research expertise and community credibility and access. o Appropriateness of the proposed budget and duration in relation to the proposed research. The review group will recommend an appropriate budget and period of support for each application that is recommended for further consideration. AWARD CRITERIA The anticipated date of the award is April 1, 1993. Factors in addition to technical merit that may be used to make award decisions include: availability of resources, and geographical distribution of awards. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jerianne Heimendinger, Sc.D., M.P.H., R.D. National Cancer Institute Division of Cancer Prevention and Control Executive Plaza North, Room 330 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-8520 FAX: (301) 402-0816 Direct inquiries regarding fiscal matters to: Catherine Blount Grants Management Specialist Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-7800 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399. 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 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50000 (Rev. Sept. 1, 1991). REFERENCES Block, G., Patterson, B., and Subar, A. (Submitted). Fruit, vegetables, and cancer prevention: A review of the epidemiologic evidence. Butrum, R., Clifford, C, and Lanza, E. 1988. NCI dietary guidelines. Am J Clin Nutr 48:888-895. California Department of Health Services. 1992. 1989 California dietary practices survey, focus on fruits and vegetables. Final report. Nutrition and Cancer Prevention Program, California Department of Health Services, California Public Health Foundation. Nutrition and Cancer Prevention Program, Sacramento, CA. Davis, R. 1988. Health education on the six-o'clock news. JAMA 259:1036-1038. Donner A., Birkett N., Buck C. 1981. Randomization by cluster: sample-size requirements and analysis. Am. J Epidemiol 114:906-914. Cornfield J. 1978. 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