$$XID RFA CA9210 CA-92-10 P1O1 ***************************************** NATIONAL BLACK LEADERSHIP INITIATIVE ON CANCER NIH GUIDE, Volume 21, Number 10, March 13, 1992 RFA: CA-92-10 P.T. 34, FC; K.W. 0715035, 0411005, 0745027, 0403004, 0795003 National Cancer Institute Letter of Intent Receipt Date: April 10, 1992 Application Receipt Date: May 21, 1992 PURPOSE The National Cancer Institute (NCI) through the Division of Cancer Prevention and Control (DCPC), Cancer Control Science Program (CCSP), National Outreach Initiatives Branch (NOIB), invites cooperative agreement applications from organizations to participate, with the assistance of the NCI, in establishing a cancer prevention and control community outreach program. This program will involve planning, developing, and implementing cancer awareness activities with lay and professional Black Americans to reduce cancer incidence and mortality rates, increase survival rates, address risk behaviors, and improve screening use and early detection rates within the U.S. Black American community. The benefits that will accrue from implementation of the objectives of this Request for Applications (RFA) will also be applicable to other indigenous populations that may reside within the specified geographical areas of the Black community. This program will evaluate individual cancer prevention and control outreach activities as well as the overall program. This program should result in measurable improvements such as 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, National Black 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, U.S. Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applicants may be domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, health boards, public health departments, territorial health departments (including the District of Columbia), volunteer organizations, clinics, coalitions, and consortia. Teams of applicants are encouraged. Among a team of applicants, one must be designated as the lead applicant and assume responsibility for conduct of the project. Foreign organizations are not eligible to apply, and applications from domestic organizations may not include international components. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT Support of this program will be through the cooperative agreement (U01), an assistance mechanism in which substantial NIH programmatic involvement with the recipient during performance of the planned activity is anticipated. The nature of NCI involvement is described in the "Terms of Cooperation" section. The award will be administered in accordance with PHS grants policy as stated in the Public Health Service Grants Policy Statement. This RFA is a one-time solicitation. Future competitive continuation applications will compete with all investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). If the NCI determines that there is a sufficient continuing program need, the NCI may invite the Awardee to submit a continuation application for review according to the procedures described in the Review Considerations section. The total award period for applications submitted in response to the present RFA may not exceed five years. FUNDS AVAILABLE Approximately $1 million in total costs per year for five years will be committed to fund one award. The total award period of this RFA must 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 a cooperative agreement pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES There are substantial data that show that Black Americans have higher overall cancer incidence and mortality rates than do whites for all but 3 of 25 primary cancer sites. (2) Even for certain types of cancers that occur less frequently in Black Americans, i.e., cancers of the bladder and corpus uteri, Black Americans have poorer survival rates compared to whites. (1) Black Americans have disproportionately larger numbers of blue-collar workers, possibly increasing the risk of certain occupationally related cancers. (3) Fewer Black Americans have adequate health insurance coverage, thereby decreasing the likelihood of access to early detection methods and state-of-the-art treatment. (3) Further, certain culturally based factors have been identified and linked to cancer within the Black American community, such as unhealthy dietary habits and negative attitudes toward health and health care. Because cancer prevention and control programs/activities are generally confronted with culturally based traditions and enormous individual resistance within minority populations, it is essential that such impediments be addressed by empowering the Black American community to act on its own behalf through facilitators who understand and are sensitive to Black American cultural traditions. This RFA will support activities involving the determination and evaluation of the efficacy of existing cancer prevention and control intervention strategies within the Black American population. Guided by the results of the evaluation of these activities, applicants will propose a strategy for the development and implementation of new NCI cancer prevention and control interventions that are specific and culturally sensitive for the U.S. Black American population. It is envisioned that the scope of the project will encompass several well-defined geographical regions of the U.S. and will involve three overlapping phases: Planning and Development (Phase I), Program Implementation and Evaluation (Phase II), and Data Analysis and Reporting (Phase III). See further details under Other, below. Background During the October 1986 meeting of the National Cancer Advisory Board (NCAB), concern was expressed regarding the targeting of tobacco and alcohol advertisements to the Black American community inasmuch as these and similar advertisements would serve to exacerbate the already disproportionately high rates of cancer among Black Americans. To address this issue, the NCAB then established a national planning committee, comprised of Black American business, education, and health professionals, to develop an operational plan for increasing community awareness about cancer. As a framework for this activity, which was named the National Black Leadership Initiative on Cancer (NBLIC), six geographical regions were identified. During the next year, regional and community-based hearings were held in six major U.S. cities (Atlanta, GA; Houston, TX; Los Angeles, CA; Chicago, IL; Washington, D.C.; and New York, NY), each of which has served since that time as the operational NBLIC headquarters for its region. NBLIC operations were supported and facilitated through an interim arrangement approved by the NCAB, by means of a supplement to the Minority Consortium Cancer Center grant. Subsequently, six Regional Coordinators were appointed, and the NBLIC concept was implemented as a program activity of the NCI. Thus, the NBLIC is the first formal outreach initiative of the NCI to develop a national network of concerned and active leaders to help address the disproportionately high cancer rates in the Black American community. Since its inception, the NBLIC has facilitated a wide variety of activities to promote cancer control and prevention activities in the Black American community. Regional Chairpersons, such as Dr. Harold Freeman and Dr. LaSalle Leffall, past presidents of the American Cancer Society, have inspired other leaders (lay and professional) in the Black American community to actively participate in NBLIC sponsored activities. The NBLIC has successfully recruited approximately 715 Black American volunteers who comprise 47 community cancer coalitions nationwide. An additional 19 NBLIC coalitions are currently being established. The program has developed strong networking relationships with approximately 200 national, state, local, grassroots, and special interest organizations across the country and has directly or indirectly affected the lives of 15-20 million Black Americans. The NBLIC continues to sponsor major national cancer awareness campaigns to Black American communities as a means of emphasizing the importance of early detection and screening. The campaigns are held during Prostate Cancer Awareness Week, Breast Cancer Awareness Month, Minority Cancer Awareness Week, and Cancer Awareness Month. Free or low cost mammograms, pap smears, and rectal exams are offered throughout the year as well as during national cancer campaigns. The campaigns encourage Black Americans to make an investment in their health. During the first funded year, the primary focus for the program was the establishment of NBLIC community cancer coalitions. These coalitions provide the structure through which the NBLIC facilitates cancer prevention and control intervention programs. In the second year, the Regional Coordinators concentrated on providing technical assistance to coalition leaders. The Coordinators and volunteer leaders firmly established coalitions and defined their role. Coalitions leaders received guidance in the areas of volunteer recruitment, demographics and cancer control needs, assessment, data gathering on cancer incidence, mortality, and survival, developing cancer resource information directories, and seeking private sources of support. The Regional Coordinators promote networking among organizations that provide cancer and health-related programs to Black Americans and among cancer survivors. They serve as liaisons between the coalitions and the various health organizations and serve as primary contacts for recruiting and accessing local resources. See Appendix A for additional examples of NBLIC activities. Other Though some technical assistance will be provided by NCI (see Terms of Cooperation, below), the applicant is responsible for conducting the activities outlined below in Phases I-III. The application must, therefore, address explicitly each of the areas identified. A. Phase I: Planning and Development The Principal Investigator (PI) of the awardee institution is responsible for detailed development and fine tuning of the overall community outreach plan. Details involving logistical matters and the hiring of qualified staff are also responsibilities of the PI. o The PI must develop a plan for outreach strategies, including an evaluation design, and identify local organizations and leaders who would participate in the implementation of dynamic and creative community outreach activities. o The PI must establish effective communication channels that allow routine exchange of ideas and status reports (financial and programmatic). The communication channels must include the PI and key staff members, Black American leaders and key staff of local Black American groups, organizations, and coalitions. o The PI must identify in-kind contributions to assist with providing support to coalitions, e.g., office space and additional equipment, such as voice mail, answering machines, and laptop computers. o The PI must describe in detail the proposed organizational structure under which these activities would be managed. The applicant must describe proposed staffing arrangements, and identify key personnel to be recruited or appointed. Use of any components of the current organizational structure is allowed but is not mandatory. An indication of the staff of the proposed NBLIC organization and the Steering Committee must be described. To assure consistency in overall administrative and programmatic operations, office procedures, and other organizational areas where miscommunication and confusion may compromise the effectiveness of the project, the PI must develop a manual of operations and procedures and distribute to key staff. B. Phase II: Implementation and Evaluation The focus during this period is the implementation of the activities described in Phase I and subsequent evaluation. The NCI will not support a project that does not have well-developed and 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. 1. 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 that permit a description of the formation and ongoing functions of community coalitions and the project as a whole. Process evaluation applications must include descriptions of the methods proposed to establish, develop, and maintain community coalitions; the interaction patterns of organizations and individuals that are included in coalitions (e.g., previously observed patterns of communication, conflict resolution, coordination, cooperation, and collaboration); methods proposed to inform and involve the community in cancer control outreach activities; and efforts planned to assure community acceptance. Process evaluation may also include detailed descriptions of tracking project activities. 2. Outcome Evaluation Outcome evaluation consists of assessing the effectiveness of the project in meeting its goals and objectives. The design of the outcome evaluation and the resulting data must be based on measurable goals. The outcome evaluation design must be rigorous enough to result in valid conclusions concerning the effectiveness and replicability of the project. Baseline data, such as cancer screening trends and rates, smoking trends and rates, cancer rates, health insurance status, pertaining to the target area are essential for a meaningful outcome evaluation. Proposed baseline data and methods for obtaining such data must be provided. Additionally, plans for periodic collection of the baseline data must be described. Descriptions of existing services in the specified area(s) and organizational structures must be provided at baseline and at each interval. While researchers should obtain as much baseline data as possible in the process of preparing the cooperative agreement application, refinement and development of key elements may occur at the beginning of the project period. The NCI will have access to all data generated under this cooperative agreement and may periodically review the data. The awardee will retain custody and primary rights to the data consistent with current HHS, PHS, and NIH policies. C. Phase III: Data Analysis and Reporting Although this phase will frequently overlap certain periods of Phase II, it is anticipated that the activities of Phase III will be most intense during the last two years of the five-year award. In conducting the analysis, the PI should consider features of the setting that may either facilitate or impede implementation of the project. The NBLIC Program Director and PI will periodically review data management procedures and will have access to all data. The awardee is responsible for selecting members of the Steering Committee. Data analysts may also be selected by the awardee to prepare reports from the data collected. Collaborative publications between the PI and NBLIC Program Director may occur subject to determination by the awardee. Copies of all publications and major presentations are to be provided to the NBLIC Program Director. SPECIAL REQUIREMENTS A. Terms of Cooperation The cooperative agreement mechanism establishes a partnership between the awardee and the NCI. The "Terms of Cooperation" Nature of Participation of NBLIC Program Director described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; HHS grant administration regulations at 45 CFR 75; other HHS, PHS, and NIH grants administration policy statements; and other NCI administrative Terms of Cooperation. Generally, the role of the NCI will be to advise, assist, and facilitate, not direct, NBLIC activities. The terms of the cooperative agreement between the grantee and NCI shall remain in effect throughout the five-year award period. 1. The NBLIC Program Director shall: o Assist the PI to facilitate project/programmatic activities including principal and ancillary functions during the award period. o Serve as a member of the NBLIC Steering Committee and report annually to the DCPC Board of Scientific Counselors. Meetings with the Steering Committee shall occur at least three times during the first year, then twice per year thereafter, to be held in Bethesda, MD. o Provide appropriate advice, assistance, and guidance in the design of activities, the recruitment of staff, and the selection of resource providers; may approve/disapprove all changes of key personnel (National Coordinator, Regional Chairpersons, and Regional Coordinators) during the award period. o Develop a schedule for periodic on-site monitoring of each project, review and evaluate technical performance, and assist in establishing new priorities. o Retain the authority to approve publications and printing costs exceeding $25,000 for a single publication. o Participate in the writing and preparation of publications and reports, subject to consent by the PI, to assure the consistency of data acquisition, analysis, and reporting. o Communicate regularly via telephone, written correspondence, and meetings with the PI. 2. The Awardee shall: o Plan, develop, implement, evaluate, and direct all aspects of the proposed project/programs including principal and ancillary functions and publish results of the initiative during Phase III. o Define the role of the Steering Committee and select members; its relationship with other committees established during the award period and how all will interact with the NBLIC Program Director. o Provide leadership, technical assistance and materials to regional offices, coalitions, and organizations to implement cancer prevention and control awareness programs. o Coordinate and monitor all NBLIC activities. o Assure participation of all key personnel in planning and bi-annual meetings. o Provide well prepared records and reports in a consistent format to the NBLIC Program Director and other Steering Committee members including semi-annual progress and annual status reports. Other information may be occasionally requested. o Include on all publications, the name, "National Black Leadership Initiative on Cancer (NBLIC)" and/or the established NBLIC logo and a by-line (including posters, pamphlets, and similar materials) identifying the NCI Cooperative Agreement number (e.g., "Supported under National Cancer Institute Cooperative Agreement Number UUUUUUUUUU"). Although the awardee retains custody of and primary rights to the data developed under this award, the NBLIC Program Director shall be provided access to all data gathered under this award for periodic review of data management procedures, data quality, and uses. o Supply computerized data, ready for analysis, to the Steering Committee, which will be comprised of the PI, National Coordinator, Regional Chairpersons, and Regional Coordinators for possible assignment to a sub-committee for data analysis. 3. Other The PI assumes responsibility for accomplishing the goals and broad objectives of the NBLIC project and related activities as defined by the NCAB. Applications must include detailed program plans that describe how all project activities relate to the overall goals and objectives of the program; how evaluation instruments and criteria will measure the impact and effectiveness; and how the NCI will benefit from the evaluation information obtained. The applicant must clearly define and justify proposed geographic program regions based on the number and distribution of Black Americans that reside within specified areas. Equally important, applicants must describe how they plan to access targeted population and the approach to be used to form coalitions. The applicant is expected to include in the application, detailed policies, procedures, and certain controls that will be in place for managing the funds and other resources. Applicant must state willingness and document ability to participate in the activities above and include those activities in the proposed budget. Applicants must state how they plan to meet the "Terms of Cooperation." Arbitration Procedures These "Terms of Cooperation" require that the NBLIC Program Director make various decisions concerning continuation of an award based on successful performance of the grantee 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 grantee'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. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS The project is national in scope and specifically targets the approximately 30 million Black American males and females of all age groups, who comprise approximately 12 percent of the U.S. population. Applicants must demonstrate the ability to access and recruit participants from the Black American community where the cancer intervention study will be conducted. The awardee and other key staff should anticipate that intervention strategies will likely differ among Black Americans in urban, suburban, and rural areas. The awardee must have the competence to adapt program activities accordingly. 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. Due to the nature of this solicitation, the inclusion of minorities as a requirement is satisfied. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. 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. For the purpose of this policy, clinical research includes 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 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 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 will be 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 project, the name, address, and telephone number of the PI, the names of other key personnel and cooperating institutions, and the number and title of the RFA in response to which the application is being submitted. The NCI requests such letters only for the purpose of providing an indication of the number of applications to be received and, therefore, usually does not acknowledge their receipt. A letter of intent is not binding and does not enter into the review of subsequent applications. It allows the NBLIC Program Director to estimate the potential review workload and to avoid possible conflict of interest in the review. In a telephone follow-up with the prospective applicant, program staff may be able to provide assistance and ascertain whether the prospective applicant has misunderstood the requirements and objectives of the RFA or opted for an inappropriate funding mechanism. The letter of intent, to be received no later than April 10, 1992, is to be mailed to: Veronica Y. Brown NBLIC Program Director National Outreach Initiatives Branch National Cancer Institute Executive Plaza South, Room 400C Bethesda, MD 20892-4200 Telephone: (301) 496-8680 APPLICATION PROCEDURES Applicants must clearly define the geographic areas where they will target their program efforts and demonstrate that the project team will be able to access all Black American groups within that area. Where specific cultural barriers are important, applicants must provide a plan for addressing those barriers. Applicants must also provide a succinct discussion of previous relevant program efforts and plans. Applicants must provide a detailed plan that describes how all project activities will be developed and implemented and how they relate to the overall goals of decreasing cancer incidence and mortality rates for Black Americans; addressing the barriers that limit or prevent Black Americans from gaining access to quality health care and referral to appropriate screening; establishing diagnostic and therapeutic cancer programs; and, stimulating greater participation of Black Americans in community outreach programs. Include in the program plan a detailed time analysis and strategy for meeting the above requirements. The program plan should reflect originality and clearly describe its scientific significance. Applicants must describe the criteria for establishing regional offices in consideration of the numbers of Black Americans in a specified geographic area. Proposed regions should have a wide variety of resources and organizations that collaboratively accomplish the goals and objectives of the program by networking with coalitions or consortia. Examples of organized groups with which to network include: Black American churches, fraternities and sororities, non-profit organizations, voluntary and health professional organizations, community service organizations, governmental organizations, universities, and the media. Applicants must describe plans to coordinate activities with government and non-government agencies to reduce duplication of effort. Include in the application an organizational structure and mechanism to facilitate communication and coordination of collaborative activities with potential networking groups and agencies such as: o NCI Office of Cancer Communications o American Stop Smoking Intervention Study Trial (ASSIST) o Cancer Information Service (CIS) o Data-based Intervention Research Program o NCI Designated Cancer Centers (comprehensive and clinical) o NCI Designated Community Clinical Oncology Programs o OCC Patient Educators Network o National Appalachia Leadership Initiative on Cancer (where appropriate) o American Cancer Society o State Health Departments o Grantees of the Centers for Disease Control's Division of Chronic Diseases Applications must include the organization's management practices that will ensure that program goals and objectives are met and funds appropriately spent during the award period. Applicants are to describe the types of prevention-control measures they intend to utilize and observations and records by which success will be measured. Applications must include an appropriately justified budget for each 12-month segment for a total of five years of funding. Applicants are strongly encouraged to identify in-kind contributions and/or co- sponsors for specific personnel activities and facilities. Applicants must also describe a fiscal structure that will allow a significant portion of the budget to be allocated for supporting coalition activities, (e.g., meetings, mailings, and programs). The overall project plan must be within the confines of the proposed budget. Estimates of staff salaries must include the Principal Investigator and other professional and support staff. In estimating travel for the five-year period, applicants must include estimates for 3 two-day meetings during Year 1 (Phase I), and 1 two-day meeting every six months thereafter in Bethesda, MD. The research grant application form PHS 398 (rev. 9/91) must be used in applying for the cooperative agreement under this RFA. These forms are available at most institutional business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892; and from the NBLIC Program Director named below. The conventional presentation format details described on form PHS 398 should be followed. The RFA label available in the grant application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of an 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 check the "YES" box. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact photocopies, in one package to: 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: Referral Officer Division of Extramural Activities National Cancer Institute Westwood Building, Room 838 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by May 21, 1992. If an application is received after that date, it will be returned to the applicant. Also, 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. Nor will the DRG 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 the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is a NCI program staff function. Applications that are judged non-responsive will be returned. Questions concerning responsiveness to the RFA should be directed to NCI program staff identified in INQUIRIES below. If the number of applications is large compared to the number of awards to be made, the NCI may conduct a preliminary technical peer review (triage) to eliminate those applications that are clearly not competitive. The NCI will remove from competition those applications judged to be noncompetitive for award and notify the applicant and institutional business official. Those applications that are complete and responsive will be evaluated in accordance with the review criteria stated below for technical merit by an ad hoc review committee convened by the Division of Extramural Activities, NCI. Applicant investigators are advised to structure their applications so as to address explicitly each of the criteria enumerated. The review group will recommend an appropriate budget and period of support for each approved application. Review Criteria Reviewers will evaluate the appropriateness and adequacy of the outreach approach and methodology proposed to carry out the program. Applicants must, therefore, document the factors that best describe cancer control needs of the target population including cancer behavior risk factors, health care utilization factors, resources and cancer rates of the population, and access to cancer data bases for the population. The qualifications and experience of proposed staff will be judged based on the degree to which they are appropriate for this program and demonstrate a broad knowledge of cancer control science and epidemiology, expertise in health intervention, nutrition, and behavioral science; experience in fiscal and administrative management of large and complex projects; experience in public health and health promotion community programs; awareness of existing cancer prevention and control needs in Black American communities; experience with multidisciplinary health care providers; and experience in collaborating with community agencies, groups, and coalitions in the conduct of cancer prevention and control intervention programs. Thorough knowledge of the Black American community, its cultural nuances, and its behavior and attitudes towards health is essential. Whereas the programs and activities initiated under this solicitation will be specifically for Black Americans within the continental United States, special consideration will be given to applicant institutions that are located within the Black community. Applicants will be judged on the degree of originality and creativity reflected in the ideas on how best to meet the goals of this announcement; the ability to identify and obtain in-kind contributions and/or co-sponsors for specific personnel, activities, and facilities; evidence of understanding the Black American community and its cancer control needs; the ability to access and obtain participation of communities, to identify and recruit lay and professional leaders, to establish community coalitions, and to collaborate with Black health care and other organizations; the expertise in establishing and maintaining viable communication channels with broadcast and print media outlets that serve the Black American community; discussion of considerations relevant to this RFA; qualifications, training, and cultural competence of the Principal Investigator, National Coordinator, and Regional Coordinators, including community outreach experience and cancer control and communications expertise; capability to perform the work proposed, and a demonstrated willingness to work together with the NBLIC Program Director. Specific review criteria are the following: 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 behavior 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 technical staffs at the awardee institution and cooperating institution, to implement the project successfully and a good 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 consideration of and sensitivity to cultural and socioeconomic factors in the community including evidence that those 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 implementation; o Adequacy, appropriateness, feasibility, and comprehensiveness of the national/regional evaluation plan including sufficient allocation of resources, maintenance of product standards, and cost containment; 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 services; o Appropriateness of procedures for establishing effective and systematic coalitions and collaborations, establishing patterns and channels of communication, mechanisms for decision-making and conflict resolution, and strategies for maintaining program cohesiveness. o Adequacy of facilities, availability of in-kind resources, and use of volunteerism to conduct the proposed outreach activities. 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. Additionally, preference will be given to applicants demonstrating compelling evidence of ability to adequately access all Black American groups targeted for outreach activities, and to those providing plans to target geographical areas of known high incidence of preventable and controllable cancers among the targeted population, e.g., areas with high incidence of cervical cancer. INQUIRIES Written and telephone inquiries concerning programmatic issues related to this RFA are encouraged and should be addressed to the NBLIC Program Director as listed under Letter of Intent. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding fiscal matters to: Eileen Natoli, Team Leader Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard 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. 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 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. National Cancer Institute, 1987 Annual Cancer Statistics Review 1973-1986. DHHS Pub. No. (NIH) 89-2789. Bethesda, MD: U.S. Department of Health and Human Services, 1988. 2. GAIL MH: A review and critique of some models used in competing risk analysis. Biometrics 31: 209-222, 1975. 3. 1992 NCI Bypass Budget. 4. National Center for Health Statistics. Health, United States, 1989. DHHS Pub. No. (PHS) 90-1232. Washington, DC: U.S. Department of Health and Human Services, 1990.