Full Text CA-92-11 APPALACHIA LEADERSHIP INITIATIVE ON CANCER NIH GUIDE, Volume 21, Number 10, March 13, 1992 RFA: CA-92-11 P.T. 34, BB Keywords: Cancer/Carcinogenesis Risk Factors/Analysis Disease Prevention+ Community/Outreach Programs Disease Control+ National Cancer Institute Letter of Intent Receipt Date: April 10, 1992 Application Receipt Date: May 21, 1992 PURPOSE The National Outreach Initiatives Branch (NOIB), Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites cooperative agreement applications from organizations to participate in establishing a strong, cancer control outreach program in Appalachia (as defined in the research objectives section below). The long-term goals of the program are to achieve reductions in cancer incidence and mortality, increases in cancer survival, and increases in the diagnosis of cancers at earlier stages within the Appalachian region. This Request for Applications (RFA) invites applications that propose mobilization of community lay and professional leaders to develop and support community cancer control coalitions throughout Appalachia. These coalitions will design and implement long-range, comprehensive, multi-disciplinary, and community-wide cancer control outreach projects and stimulate greater cancer control data collection and research efforts. As a result, measurable improvements are expected in knowledge about prevention and early detection of cancer and access and utilization of diagnostic and treatment services for cancer. 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, the Appalachia Leadership Initiative on Cancer, is related to the priority area of cancer. 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 public and private, for-profit and non-profit, organizations serving a substantial number of Appalachian clients such as universities, public health departments, voluntary organizations, research centers, hospitals, consortia of health providers, units of State and local governments, and eligible agencies of the Federal Government. Teams of applicants are encouraged. Among a team of applicants, one institution must be proposed as the lead institution to serve as the applicant and to assume responsibility for the conduct of the project. Note that awards will not be made to foreign institutions and that applications from domestic organizations may not include international components. MECHANISM OF SUPPORT Support for this program will be through the cooperative agreement (U01). The cooperative agreement is an assistance mechanism in which substantial NCI programmatic involvement with the recipients during performance of the planned activity is anticipated. The nature of NCI staff involvement is described in the Special Requirements section below. Awardees will be responsible for the planning, direction, and execution of the proposed project. The total project period for applications submitted in response to the present RFA may not exceed five years. 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) 90-50,000, revised October 1, 1990. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete as research project applications with all other investigator-initiated applications and be reviewed according to the customary peer review procedures. If the NCI determines that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competing continuation cooperative agreement applications for review. The anticipated start date for the initial awards will be September 30, 1992. FUNDS AVAILABLE Approximately $1 million in total costs per year for five years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that up to four awards will be made. The total project period of these awards may not exceed five years. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background In 1986, the National Cancer Advisory Board (NCAB) and the NCI established an outreach initiative for Black Americans because the cancer incidence and mortality rates for Blacks were disproportionately higher than those of the general population. That initiative, known as the National Black Leadership Initiative on Cancer (NBLIC), was the first formal outreach initiative of the NCI to develop a national network of concerned and active leaders to help organize, implement, and support cancer prevention programs at national and local levels. In 1989, the NCI funded a three-year follow-up phase of the NBLIC. To date, the NBLIC has established over 50 community cancer control coalitions nationwide and has directly or indirectly reached 15-20 million Black Americans, representing 50-60 percent of the U.S. Black population. Under this RFA, a similar community-coalition approach to cancer control outreach activities will be developed and implemented in a specific region of the United States, namely, Appalachia. For the 20.7 million Americans residing there, many of whom are medically underserved and of low income, cancer has become an increasing problem. Appalachia, as defined by the Appalachian Regional Development Act of 1965 and the Appalachian Regional Commission (ARC), follows the spine of the Appalachian Mountains from southern New York to northern Mississippi. It encompasses 398 counties and includes all of West Virginia and parts of twelve other states: Alabama, Georgia, Kentucky, Maryland, Mississippi, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, and Virginia (1). The region is substantially homogeneous in racial composition, with whites making up 91.8 percent of the population. Blacks are the second largest racial group with 7.3 percent, and all other races account for less than 1 percent (2). Appalachia is largely rural in nature with over 75 percent of its counties classified as non-metropolitan and rural (3). Among these rural and non-metropolitan counties, a significant proportion (23 percent) appear to be particularly economically weak or "distressed" (4). Many counties also suffer from health service shortages. According to the U.S. Health Resources and Services Administration, over 85 percent of Appalachian counties contain one or more designated Medically Underserved Areas (5) and over 65 percent contain one or more Primary Medical Care Health Professional Shortage Areas (6). Information on cancer incidence and survival in Appalachia is very limited. Since there are no standardized cancer registries covering the region, cancer incidence data are unavailable. However, death registration data indicate that in major portions of Appalachia mortality rates for the majority population from some cancers are significantly higher than overall U.S. rates (e.g., cervical) and for some cancers they are increasing significantly faster than overall U.S. rates (e.g., female breast and ovarian, and male esophagal, laryngeal, lung, bladder, and prostate) (7). In addition, information from small area cancer studies suggest high mortality rates from cancers of the lung for both males and females and cancer of the cervix (8,9). A number of surveys and small studies document very high levels of tobacco use for males and females living in Appalachia and for many states with populations living in Appalachia (10,11,12). In some areas tobacco use rates are even increasing. For example, the rate of female smoking in West Virginia increased from 27 percent in 1985 to 31 percent in 1989, and for the first time, the smoking rate for West Virginian women ages 24 to 44 surpassed that for men in the same age group (13). This RFA is being initiated to encourage applicants to assist Appalachian communities developing community coalitions that will use existing resources and state-of-the art approaches to improve cancer control efforts. The NCI considers it essential that several key community organizations and groups be involved in the development and implementation of comprehensive, community-wide programs to prevent and control cancer. Although predominately white, Appalachia is a multi-cultural area that includes a number of groups with different cultural heritages and socioeconomic strata. The geography and economics of the area are diverse, ranging from coal-dependent areas to farming, forestry, and metropolitan industrialized areas. Important variations exist among the people living in Appalachia that affect their cancer control needs, services, behaviors, and risks. Other This program is intended to improve cancer prevention and control in Appalachia through the formation of community coalitions to design, implement, and support comprehensive cancer control outreach activities. These coalitions will promote systems change in communities and facilitate the development, implementation, maintenance, and evaluation of long-range, comprehensive, multi-disciplinary, and community-wide projects. For purposes of this RFA, Appalachia is defined according to the ARC current definition that includes 398 counties in 13 states. A listing of these Appalachian states and counties is provided in Appendix A. The long-term goals of this program are: o reduce cancer incidence and mortality and improve cancer survival rates in Appalachia; o prevent future cancer incidence and mortality rate increases; o reduce the barriers preventing Appalachians from gaining access to quality cancer control services and referral to appropriate screening, diagnostic, and therapeutic cancer programs; and o stimulate greater participation of Appalachians in community cancer control outreach programs. The specific objectives are: o create a network of cancer control community coalitions throughout Appalachia; o develop, disseminate, and support effective cancer control intervention programs and strategies in Appalachian communities; o mobilize community lay and professional leaders to develop and support cancer control community coalitions and outreach activities; o stimulate cancer control data collection and research efforts in Appalachia; and o evaluate the effectiveness of this initiative. Program Implementation The program has two broad, overlapping phases: Phase I, Planning and Coordination, includes the area-wide planning and coordination of program resources and contacts; and Phase II, Implementation and Evaluation, includes the implementation, evaluation, and documentation of the program and its outreach activities. A. Phase I: Planning and Coordination During the first 12 months of the project, plans for identifying and recruiting community leaders, developing and supporting community coalitions within the geographic area defined by the Cooperative Agreement, and evaluating the project will be developed. Qualified staff will be hired which may include a full-time community coordinator and support staff. In addition, key part-time and volunteer staff may be recruited such as a well-known and respected person to serve as an overall Area Chairperson. Phase I will have the following objectives: 1. To develop a comprehensive, strategic project plan with time schedules and milestones to address all key aspects of the project. The plan should address such things as: the identity of target communities, methods to identify and recruit organizations and local leaders, strategies to establish and maintain productive relationships with cancer-related groups, methods for communities to identify the cancer control needs of the community and to design activities to meet these needs, ways to ensure area-wide program support and visibility, strategies for disseminating project findings, plans to provide on and off-site technical assistance, and methods for quality assurance. 2. To develop and implement a program management plan that includes a description of the program structure, the roles and responsibilities of key staff, and a communication system for the regular exchange of information and ideas between key staff members and local area leaders, organizations, and coalitions. 3. To develop a plan for the development and dissemination of program messages, materials, and products. This will include target groups, goals and objectives, methods of development and distribution, and evaluation. For example, public media campaigns and patient education materials may be planned in response to community-identified needs. 4. To develop a detailed evaluation plan that includes process, outcome, and cost-effectiveness measures. See "Phase II: Implementation and Evaluation" below. 5. To develop a long range plan for continued community activity and institutionalization of this outreach initiative after the expiration of the five-year cooperative agreement. The plan may include such things as obtaining in-kind contributions, fostering volunteerism, pursuing cost-containment techniques, and establishing affiliations with health care provider groups and non-profit organizations. B. Phase II: Implementation and Evaluation During the second year of the project, implementation and evaluation of outreach activities will begin according to the program plans developed in Phase I. Progress towards planning, implementation, evaluation, and documentation will be measured by milestones. The third, fourth, and fifth years will be a continuation of the activities created in years one and two. Coalitions and outreach activities will be monitored for quality and outcome effects. Special emphasis on data analysis and the dissemination of program findings will occur in year 5. The development of consortia or coalitions to achieve the objectives of this RFA is encouraged. If a consortium or coalition is proposed a clear delineation of roles and administrative procedures must be outlined in the application. If the budget request includes support for more than one unit, policies and procedures for financial and program management must be outlined in the application. A significant aim of the NCI is to improve the overall national cancer prevention and control effort by creating cohesion among cancer programs supported by the NCI and other public and private health organizations. To this end, applicants should strive to establish relationships with relevant cancer programs (e.g. cancer information programs, facilities providing cancer care, local organizations of national cancer-related organizations, and cancer or other incidence registries) in areas where they exist. C. Project Evaluation The NCI will only support projects that have well-developed, comprehensive evaluation plans. The evaluation plan must be conceptually and procedurally integrated with the overall project. It must connect implementation and outcome and specify a time frame for conducting all evaluation activities. The evaluation plan must describe the selection and development of sound measures and instruments for data collection. The application must include detailed and clearly written descriptions of process and outcome evaluation. D. Process Evaluation Process evaluation facilitates the replication of effective projects. It consists of the periodic monitoring of project implementation to document what actually was being done and to facilitate project adjustments and corrections when needed over the course of the project. It involves the collection of both quantitative and qualitative data to describe the formation and ongoing functions of community coalitions and the project as a whole. Process evaluation may include descriptions of the methods used to form, structure, and maintain community coalitions; the breadth of coalition membership and the interaction patterns of organizations and individuals in coalitions (e.g., patterns of communication, conflict, conflict resolution, coordination, cooperation, and collaboration); methods used to inform and involve the community in cancer control outreach activities; ways used to sustain trust and credibility for the program; and program costs. Process evaluation may also include detailed descriptions of project activities and their tracking. E. Outcome Evaluation Outcome evaluation consists of assessing whether or not the project was effective in meeting its objectives in ways that will lead to project goals. The design of the outcome evaluation and the resulting data should be based on clear and measurable indicators of progress toward project goals. The outcome evaluation design should be rigorous enough to result in valid conclusions concerning the effectiveness and replicability of the project. Baseline data pertaining to the target area are an essential component of a meaningful outcome evaluation. Proposed baseline data (e.g., cancer measures of the availability and utilization of cancer control services, cancer rates, tobacco use rates, and indicators of knowledge about the prevention and early detection of cancer) and methods for obtaining data must be provided. Additionally, plans for the periodic collection of the same information must be described. The importance of external resources and the likelihood of the availability should be estimated. Although awardee researchers should obtain as much baseline data as possible in the process of the preparation of the cooperative agreement application, refinement and development of key elements can occur at the beginning of the project period. In conducting the analysis, researchers should consider features of the setting (e.g., geographic, social, economic, demographic) that may either facilitate or impede implementation of the project. In addition, recommendations should be made concerning the potential for generalization of the project to other rural settings. The PIs funded under these cooperative agreements are responsible for collecting core data that are comparable across award sites. The definition of these data will be jointly decided by the Steering Committee during the first year of the project (see SPECIAL REQUIREMENTS, Terms of Cooperation). These data may include, but are not limited to: measures of coalition effectiveness; characteristics of coalitions and their numbers; descriptions of planned activities; changes in utilization of cancer control services; and the extent of media coverage and involvement. SPECIAL REQUIREMENTS Terms of Cooperation Under the cooperative agreement, a partnership exists between each recipient of the award and the NCI. The role of the NCI will be to provide program advice and technical assistance and to facilitate the performance of the effort -- not to direct Appalachia Leadership Initiative on Cancer activities. The following terms and conditions pertaining to the scope and nature of the interaction between the ALIC Program Director and the awardees will be incorporated into the Notice of Grant Award. These agreements will be in addition to the customary programmatic and financial negotiations that occur in the administration of grants. The Terms of Cooperation described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; HHS grant administrative regulations of 45 CFR 74; other HHS, PHS, and NIH grant administration policy statements; and other NCI administrative terms of award. Responsibilities of the NCI ALIC Program Director: 1. Data Management The ALIC Program Director shall provide assistance to the awardees regarding the quality and type of data to be used and its potential value to the project and shall periodically review the use of such data and provide assistance in potential further use. 2. Program Coordination and the ALIC Steering Committee The ALIC Program Director shall assist the awardees with coordination of efforts with NCI programs and grants, including coordination of efforts among other awardees funded under this RFA. The ALIC Program Director shall be a member or the ALIC Steering Committee (see Responsibilities of Awardees, 2.) and shall actively participate in meetings and will serve as liaison between the NCI and the ALIC Steering Committee. 3. Program Monitoring and Assistance The ALIC Program Director will review and approve the implementation of all project plans developed in Phase I and will develop a schedule for the periodic on-site monitoring of each project. Through telephone contacts, written correspondence, site visits, and meetings, the ALIC Program Director will provide appropriate advice, assistance, and guidance in the design of activities, the recruitment of staff, and selection of resource providers, and will monitor progress, review and evaluate technical performance, provide technical assistance, and assist in establishing new priorities. 4. Personnel The ALIC Program Director will review all key personnel recruitment and changes during the project period and may approve or disapprove any changes. Key personnel are the Principal Investigator and others specifically identified in the Notice of Grant Award. 5. Program Materials The ALIC Program Director will provide the awardee with specialized technical assistance essential to the development and distribution of effective, culturally sensitive program communication messages and materials. Responsibilities of Awardees: 1. Participation in Meetings The awardees will attend periodic NCI-coordinated meetings. These meetings will serve as a forum to exchange ideas and information on program progress. The Principal Investigators (PIs) and other appropriate project staff will attend these meetings. "Appropriate" project staff shall be identified by the ALIC Program Director and by the nature of the agenda of each meeting. Approximately two 2-day meetings will be held in Washington, D.C each year. Up to three project staff may attend, including the Principal Investigator. Travel funds for these meetings shall be included in the proposed budget. 2. The ALIC Steering Committee An ALIC Steering Committee, composed of the PI and Project Managers (the awardees' senior-most project managers under the direction of the PI) from each award, and the ALIC Project Director, will be established to provide guidance and support for program activities and to identify project-wide needs and resources. The Committee will meet three times the first year and approximately two times a year thereafter in Bethesda, Maryland, for one day. The Committee will elect a chairperson from among the PIs or Project Managers. As needed, the ALIC Steering Committee may establish subcommittees, such as a data and evaluation subcommittee, to focus on special issues. 3. Reporting requirements In addition to required annual progress reports, the awardees will provide semi-annual reports and additional information as requested by the ALIC Program Director. 4. Publications and Presentations It is expected that data and program findings will be presented and published through a variety of mechanisms to reach health professionals and the general public in Appalachia. Publication of data findings and process activities by the awardees is encouraged. Copies of reports, publications, and major presentations are to be provided to the ALIC Program Director. The awardees will acknowledge NCI support in publications and oral presentations of work supported by this cooperative agreement. 5. Data Management Although the awardees retain custody of and primary rights to the data developed under these awards, consistent with current HHS, PHS, and NIH policies, the ALIC Program Director will be provided access to all data developed under these awards for periodic review of data management procedures, data quality, and uses of such data. 6. Program Materials Program materials developed for training sessions, media campaigns, community meetings, public education, and other presentations shall be inventoried and copies provided to the ALIC Program Director. Arbitration Procedures These "Terms of Cooperation" require that the ALIC Program Director make decisions concerning continuation of an award based on successful performance of the awardees during the planning and developmental period of the cooperative agreement. Disagreements (e.g., programmatic, technical, and evaluation) arising pursuant to these approvals will be arbitrated by a panel composed of one award recipient designee, one NCI designee, and a third designee, with expertise in the relevant area, chosen by the other two. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR, Part 50, Subpart D and DHHS regulations at 45 CFR, Part 16. Other The applicants must define the geographic boundaries of the proposed project and describe in detail the plan to establish community coalitions, structural interactions among them, and interactions between coalitions and other key public and private organizations (e.g., the NCI, community health centers, hospitals, cancer centers, departments of health, and Cooperative Extension Service). Efforts to ensure community acceptance must be described, and where specific cultural barriers are important, the applicants must provide a plan for addressing these barriers. The applicants must identify the cancer prevention and control outcome measures that will be uses to evaluate the project and describe in detail the observations and records to be used. Methods of data accrual, coordination of data accrual, data analysis, and any contemplated studies or publication plans must be described. STUDY POPULATIONS The targeted population intended under this RFA is the approximately 21 million Americans living in the Appalachian region, as defined by the ARC. (See Appendix A for a listing of the 398 counties that comprise Appalachia.) Applicants responding to this RFA are expected to successfully access a significant portion of this population with the intent to decrease cancer incidence and mortality, increase cancer survival, and increase the diagnosis of cancers at earlier stages. 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 will be 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 should 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 should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2 1-4 of the Research Plan AND summarized in Section 2, E, Human Subjects. 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 United states 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. For the purpose of this policy, clinical research includes 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 application, 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 10, 1992 a letter of intent that includes a descriptive title of the proposed research, the name and address of the PI, the names of other key personnel, the 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 it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Nancy K. Simpson, Sc.M. ALIC Program Director National Outreach Initiatives Branch National Cancer Institute Executive Plaza South, Room 400-C 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-8680 APPLICATION PROCEDURES The 9/91 revision of the research grant application form PHS 398 is to be used in applying for cooperative agreements. These forms are available at most institutional business offices and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892, telephone 301/496-7441. The RFA label available in the application form PHS 398 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 2 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, exact photocopies, in one package to the address below. The photocopies must be clear and single sided. Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Hernon H. Fox Division of Extramural Activities National Cancer Institute Westwood Building, Room 838 5333 Westbard Avenue Bethesda, MD 20892 All applicants must clearly define the geographic area within Appalachia where they will target their program efforts and demonstrate that the project team will be able to access the target population. Where specific cultural barriers are important, the applicant must provide a plan for addressing these barriers. All applicants must include in the application a succinct discussion of previous relevant efforts and plans to meet the Terms of Cooperation. Applicants are encouraged to describe their ideas on how best to meet the goals of this RFA and to identify in-kind contributions and/or co-sponsors for specific personnel, activities, and facilities. Applications must be received by May 21, 1992. If an 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 Review Procedures Upon receipt, applications will be reviewed by NIH staff for completeness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI program 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 PI and institutional official. Those applications that are competitive 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. Review Criteria Applications will be judged primarily on evidence of an understanding of the Appalachian region and its cancer control needs; the ability to access and obtain participation of Appalachian communities, to identify and recruit formal and informal leaders, to establish community coalitions, and to collaborate with Appalachian health care and other organizations; discussion of considerations relevant to this RFA; qualifications of the investigators, including community outreach experience, Appalachian cultural competence, and cancer control and communications expertise; capability to perform the work proposed; and a demonstrated willingness to work together with other awardees and NCI staff. (See "Research Objectives: Program Implementation" section above.) The following criteria will be used in the review: o Comprehensiveness, feasibility, and consistency of the proposed project plan with the goals and objectives of the RFA, and the extent to which the application demonstrates originality and an understanding of cancer control outreach activities and community coalition development; o Rationale for selection of the targeted geographic area and documentation of its cancer control needs including cancer-related risk factors, access and utilization of health care services, and cancer rates; o Adequacy and soundness of the staffing and project management plans, including evidence of the capability, experience, and qualifications of the applicant and cooperating institution's technical staffs to implement the project successfully, and an overall balance of the program team in relation to the objectives of the project; o Appropriateness of the implementation plan and the extent to which it demonstrates sensitivity to cultural and socioeconomic factors in the community, including evidence that these factors are significant targets of inclusion in community coalitions; o Evidence of program linkages to existing relevant Federal, State, and local cancer control plans and activities in target communities, and a strategy for improving existing plans and stimulating their implementation; o Adequacy, appropriateness, feasibility, and comprehensiveness of the evaluation plan including sufficient allocation of resources; o Feasibility of the project within the resources and time frames proposed; appropriateness of the proposed budget and duration in relation to the proposed initiative; and inclusion of specific written agreements with cooperating institutions, including those agencies that may be providing services and/or the settings for these services. AWARD CRITERIA The anticipated date of award is September 30, 1992. Applicants will compete for funding based on the quality and merit of the proposed outreach program as determined by peer review. It is the intent of this program to cover the entire Appalachian region, and, therefore, geographic needs will be considered in making funding decisions. 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: Nancy K. Simpson, Sc.M. ALIC Program Director National Outreach Initiatives Branch National Cancer Institute Executive Plaza South, Room 400-C 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-8680 Direct inquiries regarding fiscal issues to: Eileen Natoli, Team Leader National Cancer Institute Grants Administration Branch Executive Plaza South, Room 243 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 56 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Science Program. Awards are made under the 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 part 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. REFERENCES 1. Appalachian Regional Commission. 1990 Annual Report. 2. Appalachian Regional Commission. 1990 PL-171 Census data. 3. National Cancer Institute. U.S. Department of Agriculture Rural-Urban Continuum Codes, 1980 Census data. 4. Appalachian Regional Commission. FY 1988 Distressed Rural Counties. 5. U.S. Department of Health and Human Services, Health Resources and Services Administration. Designation of Medically Underserved Areas. Federal Register, Vol. 41, No. 201, Friday, October 15, 1976; Federal Register, November 12, 1982; and Bureau of Health Care Delivery and Assistance (BHCDA) case by case updates. 6. U.S. Department of Health and Human Services, Health Resources and Services Administration. List of Designated Primary Medical Care Health Professional Shortage Areas (HPSAs). Federal Register, Vol.56, No. 188, Friday, September 27, 1991. 7. Pickle, L.W.; Mason, T.J.; Howard, N.; Hoover, R.; Fraumeni, Jr., J.F. Atlas of U.S. Cancer Mortality Among Whites: 1950-1980. National Cancer Institute. DHHS Publication No. (NIH) 87-2900. 8. Tucker, T.C.; Friedell, G.H.; Stallones, L.; Thompson, J. R.; Bagby, J.W. Cancer Mortality in Rural Appalachian Kentucky. Appalachian Data Bank Report #6, November 1988. 9. National Cancer Institute. Cancer Statistics Review 1973-88. Ries, L.A.G.; Hankey, B.F.; Miller, B.A.; Hartman, A.M.; Edwards, B.K. (eds.) DHHS Publication No. (NIH) 91-2789. 10. Johnson, T.P; Frank, A.L.; Hougland, J.G.; Moore, R.W.; Ford, T.R. Health Experience and Behavior Among Appalachian and Non-Appalachian Kentuckians: Results from the Kentucky Health Survey. (In) Health in Appalachia, Proceedings from the 1988 Conference on Appalachia, November 3-5, 1988. University of Kentucky. 11. Shopland, D.R.; Niemcryk, S.J.; Marconi, K.M. Geographic and Gender Variations in Total Tobacco Use. NCI Report (undated). 12. U.S. Department of Health and Human Services, National Heart, Lung, and Blood, Institute (NHLBI). NHLBI Data Fact Sheet: Cardiovascular Disease Risk Factors, March 1991. 13. State of West Virginia. 1990 State Health Plan. APPENDIX A APPALACHIAN STATES AND COUNTIES* Alabama: Bibb, Blount, Calhoun, Chambers, Cherokee, Chilton, Clay, Cleburne, Clobert, Coosa, Cullman, De Kalb, Elmore, Etowah, Fayette, Franklin, Jackson, Jefferson, Lamar, Lauderdale, Lawrence, Limestone, Madison, Marion, Marshall, Morgan, Pickens, Randolph, St. Clair, Shelby, Talladega, Tallapoosa, Tuscaloosa, Walker, Winston Georgia: Banks, Barrow, Bartow, Carroll, Catoosa, Chattooga, Cherokee, Dade, Dawson, Douglas, Fannin, Floyd, Forsyth, Franklin, Gilmer, Gordon, Gwinnett, Habersham, Hall, Haralson, Heard, Jackson, Lumpkin, Madison, Murray, Paulding, Pickens, Polk, Rabun, Stephens, Towns, Union, Walker, White, Whitfield Kentucky: Adair, Bath, Bell, Boyd, Breathitt, Carter, Casey, Clark, Clay, Clinton, Cumberland, Elliott, Estill, Fleming, Floyd, Garrard, Green, Greenup, Harlan, Jackson, Johnson, Knott, Knox, Laurel, Lawrence, Lee, Leslie, Letcher, Lewis, Lincoln, McCreary, Madison, Magoffin, Martin, Menifee, Monroe, Montgomery, Morgan, Owsley, Perry, Pike, Powell, Pulaski, Rockcastle, Rowan, Russell, Wayne, Whitley, Wolfe Maryland: Allegany, Garrett, Washington Mississippi: Alcorn, Benton, Chickasaw, Choctaw, Clay, Itawamba, Kemper, Lee, Lowndes, Marshall, Monroe, Noxubee, Oktibbeha, Pontotoc, Prentiss, Tippah, Tishomingo, Union, Webster, Winston, New York: Allegany, Broome, Cattaraugus, Chautauqua, Chemung, Chenango, Cortland, Delaware, Otsego, Schoharie, Schuyler, Steuben, Tioga, Tompkins North Carolina: Alexander, Alleghany, Ashe, Avery, Buncombe, Burke, Caldwell, Cherokee, Clay, Davie, Forsyth, Graham, Haywood, Henderson, Jackson, McDowell, Macon, Madison, Mitchell, Polk, Rutherford, Stokes, Surry, Swain, Transylvania, Watauga, Wilkes, Yadkin, Yancey Ohio: Adams, Athens, Belmont, Brown, Carroll, Clermont, Columbiana, Coshocton, Gallia, Guernsey, Harrison, Highland, Hocking, Holmes, Jackson, Jefferson, Lawrence, Meigs, Monroe, Morgan, Muskingum, Noble, Perry, Pike, Ross, Scioto, Tuscarawas, Vinton, Washington Pennsylvania: Allegheny, Armstrong, Beaver, Bedford, Blair, Bradford, Butler, Cambria, Cameron, Carbon, Centre, Clarion, Clearfield, Clinton, Columbia, Crawford, Elk, Erie, Fayette, Forest, Fulton, Greene, Huntingdon, Indiana, Jefferson, Juniata, Lackawanna, Lawrence, Luzerne, Lycoming, McKean, Mercer, Mifflin, Monroe, Montour, Northumberland, Perry, Pike, Potter, Schuylkill, Snyder, Somerset, Sullivan, Susquehanna, Tioga, Union, Venango, Warren, Washington, Wayne, Westmoreland, Wyoming South Carolina: Anderson, Cherokee, Greenville, Oconee, Pickens, Spartanburg Tennessee: Anderson, Bledsoe, Blount, Bradley, Campbell, Cannon, Carter, Claiborne, Clay, Cocke, Coffee, Cumberland, De Kalb, Fentress, Franklin, Grainger, Greene, Grundy, Hamblen, Hamilton, Hancock, Hawkins, Jackson, Jefferson, Johnson, Knox, Loudon, McMinn, Macon, Marion, Meigs, Monroe, Morgan, Overton, Pickett, Polk, Putnam, Rhea, Roane, Scott, Sequatchie, Sevier, Smith, Sullivan, Unicoi, Union, Van Buren, Warren, Washington, White Virginia: Alleghany, Bath, Bland, Botetourt, Buchanan, Carroll, Craig, Dickenson, Floyd, Giles, Grayson, Highland, Lee, Pulaski, Russell, Scott, Smyth, Tazewell, Washington, Wise, Wythe West Virginia: Barbour, Berkeley, Boone, Braxton, Brooke, Cabell, Calhoun, Clay, Doddridge, Fayette, Gilmer, Grant, Greenbrier, Hampshire, Hancock, Hardy, Harrison, Jackson, Jefferson, Kanawha, Lewis, Lincoln, Logan, McDowell, Marion, Marshall, Mason, Mercer, Mineral, Mingo, Monongalia, Monroe, Morgan, Nicholas, Ohio, Pendleton, Pleasants, Pocahontas, Preston, Putnam, Raleigh, Randolph, Ritchie, Roane, Summers, Taylor, Tucker, Tyler, Upshur, Wayne, Webster, Wetzel, Wirt, Wood, Wyoming * Defined by the Appalachian Regional Commission (ARC), 1990. .
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