Full Text CA-97-022 INFORMATICS SUPPORT FOR BREAST AND COLON CANCER COOPERATIVE FAMILY REGISTRIES NIH GUIDE, Volume 26, Number 25, August 1, 1997 RFA: CA-97-022 P.T. 34 Keywords: 0710078 Cancer/Carcinogenesis 0715036 Registries+ National Cancer Institute Letter of Intent Receipt Date: September 3, 1997 Application Receipt Date: October 7, 1997 PURPOSE The Extramural Epidemiology and Genetics Program (EEGP), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) invites applications from organizations with demonstrated excellence in information technology (informatics, software development), and operations management (coordination of participating centers, data management and quality assurance, biostatistics and study methodology) for a cooperative agreement (U01) for an Informatics Center (IC) for the NCI Cooperative Family Registries for Breast and Colon Cancer (see RFAs CA-95-003 and CA-96-011). Applicants are referred to the earlier RFAs for a full description of the purpose and organization of the Cooperative Family Registries for Breast and Colon Cancer Studies (CFRBCCS). Copies of the earlier RFAs can be obtained by request from the contact names listed in INQUIRIES, below. The purpose of the current solicitation is to provide technical assistance and resource support services for the Registries. The Registries represent an interdisciplinary consortium of participating centers of excellence in clinical and human genetics and epidemiology, funded as cooperative agreements. The Registries serve as a research infrastructure by linking the collective scientific expertise of the collaborating centers with study populations through a central registry of participating families, and providing access to scientific expertise beyond the scope of a single institution or organization. Technical skills and support services are required to: (1) assist the CFRBCCS investigators to assure the establishment, management and continuing quality of the CFRBCCS databases, including epidemiologic, clinical and repository-related information; (2) provide the technical expertise for the development of key information technologies, statistical methodology and study design that will be integral to the development of the next generation of cancer genetics studies; and (3) provide the technical expertise and training to the CFRBCCS necessary to develop, implement and maintain a central informatics system that facilitates the goals of the Registries and is secure and confidential. 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 Request for Applications (RFA) 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applicant institutions need not have a formal affiliation with an academic program in human genetics. However, experience in research related to genetic epidemiology and in the design and conduct of multi-site projects with data collection, management and quality assurance is highly desirable. Applications from centers of interdisciplinary research excellence, such as cancer centers, are encouraged. Applications from racial/ethnic minority individuals, women, and persons with disabilities as Principal Investigators are also encouraged. MECHANISM OF SUPPORT Support for this program will be through the cooperative agreement (U01). Substantial programmatic NCI involvement with the recipients is anticipated during development, implementation, and performance. Under the cooperative agreement, NCI will assist, support and/or stimulate the recipient's activities, working jointly with the participating centers and with the IC in a partnership role. Participating organizations will be responsible for planning and executing the proposed projects. Details of the responsibilities, relationship and governance of the project to be funded under cooperative agreements are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA should not exceed five years. The anticipated award date is April 1, 1998. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. This RFA is a one-time solicitation. At this time the NCI has not determined whether or how this solicitation will be continued beyond the present RFA. Except as otherwise stated in the RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000 (Rev.) April 1, 1994. FUNDS AVAILABLE Approximately $850,000 in total costs per year for five years will be committed to fund applications that are submitted in response to this RFA; the NCI anticipates making one award as a result of this RFA. Funding beyond the first and subsequent years of the cooperative agreement will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background The rapid identification of cancer susceptibility genes and the commercial availability of predictive genetic testing have created an urgent need for research to define the clinical implications of inherited mutations, including factors that modulate gene expression and potential preventive interventions, and to communicate up-to-date information about cancer genetics, genetic testing and cancer risk to health care providers and other interested individuals. To obtain answers to the next generation of questions in human cancer genetics, studies of unprecedented size and complexity will be required. By providing an infrastructure for interdisciplinary genetic epidemiology research, the CFRBCCS, in concert with other initiatives, will further our understanding of the genetics of cancer susceptibility, facilitate the translation of research findings into medical practice and address pressing public health issues. The strength of both the Breast and Colon Cancer Registries is based on the multicenter, multidisciplinary talents brought by the various teams and investigators, and on the collection of epidemiologic, clinical and family history data as well as biological specimens from participating families. The IC will provide the means to achieve cross-site analyses. The Cooperative Family Registry for Breast Cancer Studies is a network of investigators at seven sites who have had cooperative agreements since 1995 to collect pedigree information, epidemiologic and clinical data, and biological specimens from individuals and patients with a family history of breast cancer to provide a resource for basic, clinical, epidemiologic, and behavioral breast cancer genetics research, and to identify a population at high risk for breast cancer that could benefit from new preventive and therapeutic strategies. In the past two years, the Breast Cancer Registry has developed core protocols and questionnaires, as well as site-specific protocols reflecting the specific expertise and capability of each center. Participating Breast Cancer Registry institutions include: Northern California Cancer Center, Ontario Cancer Treatment and Research Foundation, Memorial Sloan-Kettering Cancer Center, University of Melbourne, Fox Chase Cancer Center, Huntsman Cancer Institute, University of California at Irvine. Recruitment of Breast Cancer Registry subjects is now actively underway; an estimated total of 8,000 families are projected to be enrolled during the coming two and one-half years. Similar to the Breast Cancer Registry, the Cooperative Family Registry for Epidemiologic Studies of Colon Cancer is envisioned to be a multi-center Registry which serves as a research resource to the scientific community. Plans for data collection are similar to the Breast Cancer Registry; in addition, genetic characterization is to be performed and population-based controls are to be accrued. The IC shall provide support to the Colon Cancer Registry as well as the Breast Cancer Registry. Six Colon Cancer Registry awards are pending. A total of 11,000 families are projected to be enrolled in the Colon Cancer Registry within five years. Illustrative of CFRBCCS projects that are envisioned but which require analysis of multi-site data to achieve adequate power include: Descriptive studies of the prevalence of carriers of specific mutations by ethnicity, religious affiliation, prior primary breast and colon cancer history, etc; assessment of the risk of breast and other cancers by mutation status and other demographic variables; and age-adjusted stage-specific survival from breast and colon cancer among mutation carriers; Pathology studies of the distribution of histologic types among breast and colon cancer cases with specific mutations; Etiologic studies of gene-gene and gene-environmental interactions including variables such as reproductive factors, alcohol consumption, body size, diet, physical activity, and radiation exposure; Psychosocial studies of the impact of registry participation on anxiety, family dynamics; the impact of genetic testing on psychological well-being; and the effectiveness of various interventions to increase understanding of genetic testing and to reduce anxiety; Pathology-based studies which compare histopathologic and molecular characteristics in carriers vs. non-carriers according to various demographic and epidemiologic characteristics. There is a need to provide for coordination of the central database that will permit ready access to cross-site core data from the Registries, conduct range and quality control checks, and ensure the confidentiality of the highly sensitive data. The central database will also include data collected in pilot studies approved by the Advisory and Steering Committees of the Registries (see Collaborative Responsibilities) and data generated from studies conducted by outside investigators who use Registry data for their investigations. Research Goals and Scope This RFA seeks to stimulate a cooperative effort to develop key information technologies and operational systems. Substantial effort should be directed towards design, implementation, maintenance, and technologic advancement of basic Registry activities. To facilitate these functions, this RFA will provide a broad base of support for technical services and developmental research, such as research on key information technologies, statistical methodology and study design integral to cancer genetics studies. Funds may be requested for personnel, for equipment, and for specific research projects relevant to development, implementation and support of the Registries. This RFA will support one group to develop the informatics infrastructure to support the CFRBCCS. Specifically, in collaboration with investigators from the Registry centers, the IC shall, at a minimum: Coordinate the activities of the operations units at the Registry centers, which are providing statistical and logistical support to the local centers as well as preparing data for the central databases; Provide information and software to support local entry of data that will go into the central databases; Provide training materials and conduct on-site training when needed to ensure consistency and quality control of data collection; Perform quality control checks of data collected and entered at local sites but submitted to the central databases, and provide timely feedback to sites to enhance quality control of data collection and entry; Provide service statistics to NCI program officials and to the Advisory and Steering Committees of the Registries concerning recruitment, retention, and protocol compliance; Conduct analyses of cross-site data at the request of Registry investigators or NCI program officials, as approved by the Steering Committees of the Registries; Develop and maintain anonymous databases for use as a research resource as approved by the Advisory Committees of the CFRBCCS; Promote information dissemination through newsletters and a WWW site. SPECIAL REQUIREMENTS Applicants must have existing programs of scientific excellence and technical expertise in areas relevant to the type of application submitted. All applications must address the following questions in a clear and organized manner: (1) How will existing (and proposed) resources and expertise support specific tasks in Registry development and implementation; contribute to support and maintenance of Registry functions; and present unique opportunities for Registry activities? (2) How does past technical experience and performance support the applicant's ability to provide the required technical services; demonstrate the scientific expertise and the ability to apply scientific considerations to technical functions; and show the applicant's ability and willingness to collaborate effectively as a member of a consortium? Study Organization and Function The NCI Cooperative Cancer Family Registries represent a consortium of participating centers of excellence in interdisciplinary genetic epidemiology research that will be linked in a dynamic and interactive fashion through the central informatics and operations functions of the IC into a research resource. To ensure close integration between the IC and the Registry participating centers, the Principal Investigator (PI) of the IC will serve as a full voting member of the Steering Committees of the Registries. The external Advisory Committees (ACs) of the Registries consist of senior scientists with multidisciplinary expertise in cancer genetics research and are responsible for reviewing, evaluating and prioritizing all research proposals involving the Registries. This will include proposals made by the IC. AC members are nominated by the members of the Steering Committees (SCs) and will be appointed by the NCI for a two-year tenure. Terms and Conditions of Award The Terms and Conditions of Award, below, will be included in any award issued as a result of this RFA. It is critical that each applicant include specific plans for responding to these terms. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations in 45 CFR Part 74 and 92, and other HHS, PHS and NIH grant administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement (U01). This is an assistance mechanism for support of a research resource in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH assist, supports and/or stimulates the recipient's activities, by facilitating performance of the program effort in a partner role. Consistent with this concept, the prime responsibility for the activity resides with the awardee for the project as a whole. I. Awardee Rights and Responsibilities The Informatics Center (IC) awardee will have primary rights and responsibilities to define projects and approaches and to plan and conduct the work of the IC. The IC will have engage in methodological and developmental investigations, and develop novel methodological approaches, using data from the CFRBCCS. The development of standardized instruments for data collection and management for this large multi-site project will provide an opportunity for methodological research that can be exported to other centers engaged in the informatics support of genetic studies. Responsibilities of the IC will include: A. Statistical and Research Design. The IC will provide intellectual input about statistical issues, study design and methodology for the Registries. The IC's responsibilities will include: 1. Providing expert statistical assistance to CFRBCCS investigators in developing design and analytic approaches, estimating sample size requirements for specific research questions, planning and performing interim and final analyses, and preparing reports that summarize the results of such analyses. Expertise in modeling, repeated methods, exploratory data analysis and robust methods will be important for the investigations supported by the CFRBCCS; and 2. Developing approaches to statistical modeling, analysis, and study design to maximize the efficiency of genetic epidemiology studies performed using Registry resources, especially the investigation of gene-gene and gene-environment interactions. B. Data Management and Quality Assurance. 1. The IC will establish an optimal computing environment for processing, storage and retrieval of data through a central data management facility or a distributed data system, including multiple sets of longitudinal data and creation of data files for specific analyses. The IC will maintain and update an information management system for tracking data from the study sites as well as maintain and update codebooks, active files and inventory files. Combined codebooks may need to be created to interface with other genetics and epidemiology databases, such as the Cancer Genetics Network. Archiving of data should be provided. Record-keeping and encrypting procedures should ensure confidentiality of data with personal identifiers. 2. A study-wide quality assurance system should be developed and implemented by the IC to allow for regular evaluation of reliability, validity and completeness of CFRBCCS databases. The IC should provide documentation of any changes in the quality assurance and data entry instruction manuals. The IC should site visit CFRBCCS centers during the first two years of funding, the schedule to be developed in consultation with the ACs and the NCI. The IC should bring any data suggesting quality assurance problems at study sites to the attention of the NCI and the SCs. The IC will play a central role in discussing such problems and suggesting solutions at the periodic AC meetings. 3. The data processing, storage and retrieval procedures and quality assurance systems of the IC will need to be approved by the SCs before implementation. 4. The IC will monitor adherence to the clinical and laboratory protocols, and will coordinate implementation of new or modified protocols approved by the SCs. IC activities related to new or modified protocols include new data collection form development, data management system modifications, operations and training manual updates, and study site staff training. C. Specimen Tracking System for the Storage and Retrieval of Biological Specimens. The IC should provide central coordination of stored specimens in collaboration with Registry site investigators. This includes updating and improving as needed a system for specimen tracking at each stage (collection, processing, transfer, storage and retrieval). The IC should also plan to maintain an electronic inventory updated biannually and integrated into the Registry databases. This inventory should list all specimens from each clinical site, describing the type and quantity of all specimens. To facilitate the evaluation of new studies by the AC, a repository status summary should be prepared and distributed to the AC members before their scheduled meetings. The IC should record requests for biological specimens and work with the repository and the SCs to account for the current amount and type of specimens available. D. Summary Data and Support and Coordination for Data Presentation. 1. The IC will be responsible for preparing and updating operations manuals and data collection forms and providing regular statistical summary reports to the CFRBCCS sites and the NCI, including summary data on descriptive statistics and response rates of the study participants. 2. The IC should coordinate with Registry investigators the process of generating scientific material for presentations at conferences and meetings. The IC should provide datasets for analysis by Registry investigators and outside collaborators, as requested by the SC. The IC will maintain and regularly distribute a list of all publications, manuscripts and presentations that use data from the CFRBCCS. E. Study-wide Communication, Coordination and Administrative Duties. The IC will have overall responsibility for the following activities: 1. Establishing electronic mail linkages among CFRBCCS sites and the NCI; 2. Developing milestones/time lines to identify major steps and anticipated accomplishments. Particular attention is suggested in setting milestones in the following areas: methods of data input; distribution of instruments/operation manuals; ongoing training of Registry site staff; and implementation of quality assurance protocols; 3. Providing regular data "freezes," based on a schedule established by the SCs; 4. Providing meeting-related support for SCs and ACs and working group meetings by distributing agendas and other materials and preparing highlights of meetings and conference calls; and 5. Developing and updating a CFRBCCS WWW site, and, in cooperation with the participating sites, developing a regular newsletter for distribution by the sites to participants. F. Communications with Registry Sites and NCI. Regular reporting of activities will help the Registry sites and the NCI to monitor progress and identify areas of potential interest for further investigation. G. Informatics and Information Technology Development. The IC will develop computer-based tools which will facilitate the data collection and distribution goals of the Registries. This responsibility will include development, implementation and maintenance of an information management system for core data. This management system will incorporate safeguards such as encryption technologies to ensure confidentiality and strictly limit access to databases. The information management system will be flexible enough to accommodate follow-up data collections and to integrate data generated through additional studies which use these resources. H. Software for Genetic Epidemiology Research. The IC will survey research needs for software and Internet-based applications to facilitate the collection, integration and analysis of genetic and pedigree data, evaluate existing software and develop new materials as needed, which will be made available to the genetic epidemiology community. I. Developmental Studies. The IC will provide technical expertise for the development of key information technologies, statistical methodology and study designs that will be integral to the development of the next generation of cancer genetics studies. II. The NCI Program Coordinator will: A. Serve as liaison from the NCI, specifically to coordinate activities among the IC, the Registry awardees, and the NCI program coordinator for the Registries (see INQUIRIES); B. Serve as scientific liaison between the awardees and other program staff at NCI with experience in informatics and multicenter studies; C. Serve as a full participant and voting member of the Registry SCs, and, as appropriate, their subcommittees; and attend AC meetings in a non-voting liaison member role; D. Assist the IC in the standardization of data collection methods across Registry participating centers for data that will go into the central databases; assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations in data collection that require coordinated action; and assist in developing plans for information dissemination through newsletter and a WWW site. The NCI reserves the right to reduce the budget, to withhold support, and to suspend, terminate or curtail a study or an award in the event of delinquent data reporting, inadequate quality control of data collection, refusal to carry out the recommendations of the SCs or ACs, or substantial failure to comply with the terms of the award. Periodic external progress reviews of the program will be carried out as NCI deems appropriate. III. Collaborative Responsibilities The IC awardee will, in a dynamic and interactive fashion, link the NCI Cooperative Cancer Family Registries into a research resource. The PI of the IC will serve as a full voting member of the Steering Committees (SCs) of the Registries. The SCs for the Registries are responsible for development and implementation of CFRBCCS policies and procedures, integrating and coordinating activities of the participating centers and the IC. The SCs have responsibility for approving the procedures for data processing, storage, retrieval and quality assurance that are study-wide. The external Advisory Committees (ACs) of the Registries will evaluate all research proposals (those from Registry investigators as well as from the external research community) on a regular basis. This will include research proposals made by the IC. All reviews will be held according to rules pertaining to the conduct of reviews for NIH grants, contracts, and cooperative agreements, with special attention to issues of conflict of interest (whether real or apparent). The ACs will provide recommendations to the SCs as to the priority of the proposed research projects. The ACs will also provide advice to the SCs on scientific matters, as appropriate and as needed. The IC will provide data to the AC regarding recruitment and repository contents, and provide data for support of research approved by the SCs and ACs. IV. Arbitration Procedures Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NCI may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the awardee, a second member selected by NCI, and the third member selected by the two previously selected members. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research" which have been published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by September 3, 1997, a letter of intent that includes a descriptive title of the proposed project, the name, address and a telephone number of the Principal Investigator, the names of other key personnel and participating institutions, and the number and title of the RFA in response to which the 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 is helpful in planning for the review of applications. It allows NCI staff to estimate the potential workload and to avoid conflicts of interest in the review. The letter of intent is to be sent to Amy Sheon, Ph.D., at the address listed under INQUIRIES below. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Suite 6095, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, e-mail asknih@odrockm1.od.nih.gov. The RFA label available in the application form PHS 398 (rev. 5/95) must be affixed to the bottom of the face page. 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 number and title of the RFA must be typed on line 2 of the face page of the application and YES must be checked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies in one package to the Division of Research Grants at the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must by sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Blvd. Rockville, MD 20850 (if hand delivered or delivery service) Bethesda MD 20892-7399 (if using U.S. Postal Service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the application will be reviewed in competition with other applications received on or before the designated receipt date. Applications must be received by October 7, 1997. If an application is received after that date, it will be returned to the applicant without review. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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 All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the OBJECTIVES of the RFA. Although the technical merit of the proposed protocol is important, it will not be the sole criterion of evaluation of a study. Review Method Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness to the RFA by the NCI. Incomplete applications will be returned to the applicant without further consideration. If NCI staff find that the application is not responsive to the RFA, it will be returned and receive no further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process by which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria Applications for IC awards will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the OBJECTIVES of the RFA. Although the technical merit of the proposed protocol is important, it will not be the sole criterion of evaluation of an application. Applicants are expected to address all issues identified under SPECIAL REQUIREMENTS of the RFA. In addition, applicants will be evaluated based on the additional criteria listed below. Applications for the IC will be reviewed on the basis of the following criteria: 1. Scientific excellence of the application and the extent to which it addresses the special scientific and technical program requirements presented in the RFA; 2. The adequacy of the applicant's plan for safeguarding confidentiality of the central Registry database and providing technical advice to Registry participating centers in developing protocols to ensure local data security; 3. Demonstrated ability and willingness to provide technical assistance for the development of informatics structures for collaborative multi-center research; 4. Qualifications and research experience of the Principal Investigator and staff with regard to development and implementation of complex informatics structures; previous experience with design and administration and analysis of data from multi-institutional clinical trials and relevant epidemiologic or laboratory studies; competence with regard to the mechanisms for administration, experimental design, quality control, study monitoring, data management and reporting, statistical analysis, and compliance with regulatory requirements; 5. The adequacy of existing physical facilities and resources of the applicants' institution(s); how effectively any proposed resource expansion will enhance the applicant's participation in Registry functions; and the unique resources and capabilities the applicant will bring to the Registries; 6. Adequacy of plans for effective communication and coordination between the participating centers, IC, and NCI; 7. Appropriateness and adequacy of proposed developmental and methodological studies; and 8. Scientific and technical merit of the proposed project as determined by peer review. The review group will also examine the proposed budget and will recommend an appropriate budget and period of support for each application that is recommended for further consideration. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. AWARD CRITERIA Applications recommended by the National Cancer Advisory Board will be considered for award based upon technical merit of the application as reflected in the priority score, availability of resources, and availability of funds. Furthermore, the applicant organization must indicate a commitment to accept provisions outlined under the SPECIAL REQUIREMENTS section, Terms and Conditions of Award. The earliest anticipated date of award is April 1, 1998. INQUIRIES Written and telephone inquiries concerning the RFA and the opportunity to clarify any issues or questions from potential applications are welcome. Direct inquiries regarding RFA-related programmatic and scientific issues to: Amy Sheon, Ph.D. Division of Cancer Epidemiology and Genetics National Cancer Institute 6130 Executive Boulevard, Suite 535 - MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 Email: as31r@nih.gov Direct inquiries regarding the CFRBCCS to: Daniela Seminara, Ph.D., M.P.H. Division of Cancer Epidemiology and Genetics National Cancer Institute 6130 Executive Boulevard, Suite 535 - MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 Direct inquiries regarding fiscal matters to: Ms. Crystal Wolfrey Grants Management Specialist National Cancer Institute 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 282 Email: wolfreyc@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No.93.393, Cancer Cause and Prevention Research. 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 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Unless otherwise noted all PHS grants policies apply. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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