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COMMUNITY CLINICAL ONCOLOGY PROGRAM Release Date: March 13, 2000 RFA: CA-01-004 National Cancer Institute Letter of Intent Receipt Date: June 9, 2000 Application Receipt Date: July 14, 2000 PURPOSE The Division of Cancer Prevention (DCP), National Cancer Institute (NCI), invites domestic institutions to apply for cooperative agreements in response to this Community Clinical Oncology Program (CCOP) Request for Applications (RFA). Applicants for new and currently funded Community Clinical Oncology Programs (CCOP) and research bases are invited to respond to this RFA. Using the national resource of highly trained oncologists in community practice, the CCOP: 1) provides support for expanding the clinical research effort in the community setting; 2) stimulates quality care in the community through participation in protocol studies; 3) fosters the growth and development of a scientifically viable community cancer network able to work closely with NCI-supported clinical cooperative groups and cancer centers; 4) supports development of and community participation in cancer prevention and control intervention research, which includes chemoprevention, biomarkers and early detection, symptom management, rehabilitation, and continuing care research; 5) involves primary care providers and other specialists in cancer prevention and control clinical trials; and 6) increases the involvement of minority and underserved populations in clinical research. Combining the expertise of community physicians and other health care professionals with NCI-approved cancer treatment and prevention and control clinical trials provides the opportunity for the transfer of the latest research findings to the community level. This reissuance of the CCOP RFA seeks to build on the strength and demonstrated success of the CCOP over the past seventeen years by: 1) continuing the program as a vehicle for supporting community participation in cancer treatment and prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI); 2) expanding and strengthening the cancer prevention and control research effort; 3) utilizing the CCOP network for conducting NCI-assisted cancer prevention and control research; and 4) evaluating on a continuing basis CCOP performance and its impact in the community. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA, Community Clinical Oncology Program, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted from domestic institutions for cooperative agreements to continue the Community Clinical Oncology Program (CCOP). New applicants and currently funded programs are eligible as described below. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. A. CCOP Applicants 1. An applicant may be a hospital, a clinic, a group of practicing physicians, a health maintenance organization (HMO), or a consortium of hospitals and/or clinics and/or physicians and/or HMOs that agree to work together with a principal investigator and a single administrative focus. 2. A university, Veterans Administration hospital, or military treatment facility (MTF) may be included in an application as a member of a consortium led by a community institution, but may not be the applicant organization or the major contributor to accrual. An unfunded, non-university clinical trials cooperative group member is eligible to apply. 3. Funded cooperative group affiliate programs are eligible to apply, but should state in the application that support through this mechanism will be relinquished if a CCOP award is received. 4. Institutions not eligible to apply as the CCOP applicant organization include: a. A comprehensive, consortial, or clinical cancer center holding an NCI Cancer Center Support (Core) grant; b. A university hospital that is the major teaching institution for that university; or c. A university hospital clinical trials cooperative group member funded by the Division of Cancer Treatment and Diagnosis (DCTD), NCI. B. Research Base Applicants An applicant may be: 1. An NCI-funded clinical trials cooperative oncology group; 2. An NCI-funded clinical center, consortium, or comprehensive cancer center. Cooperative groups must participate in both cancer treatment and prevention and control clinical trials; cancer centers as CCOP research bases may participate in both cancer treatment and prevention and control studies or cancer prevention and control research only. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U10), an "assistance" mechanism (rather than an "acquisition" mechanism), 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 purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to this RFA may not exceed 3 years for new applicants, and no more than 5 years for applicants currently supported under this program. Currently supported applicants will be funded for 3, 4, or 5 years depending upon priority score/percentile, review committee recommendations, and programmatic considerations. The anticipated award date is June 1, 2001. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of awards will vary also. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. 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. NCI has determined that there is a continuing program need for community participation in cancer clinical research trials, both cancer treatment and prevention and control. While this RFA is a one-time issuance, it is expected that a CCOP RFA will be published in the NIH Guide for Grants and Contracts annually in the future provided that funds are available. FUNDS AVAILABLE It is anticipated that up to $8.7 million in total costs per year for 5 years will be committed to specifically fund applications which are submitted in response to this RFA. Approximately eight (8) research base awards and nine (9) CCOP awards will be made. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. An additional $28.3 million in total costs per year for 5 years will be committed to specifically fund several large ongoing chemoprevention trials that are being implemented through the CCOP network. Although this program is provided for in the financial plans of NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The CCOP was initiated in 1983 to bring the benefits of clinical research to cancer patients in their own communities by providing support for physicians to enter patients onto treatment research protocols. In the first three years of the CCOP, 62 community programs in 34 states were funded and accrued 14,000 patients to NCI approved treatment clinical trials. The CCOPs were clearly effective in accruing patients to treatment clinical trials. The second CCOP RFA, issued in 1986, expanded the focus to include cancer prevention and control research based on the rationale that the multi- institutional clinical trials model essential for testing new treatment regimens is also central for conducting large-scale cancer prevention and control trials. In 1999, there were programs in 31 states involving over 345 hospitals and over 3,900 physicians. Approximately 5,235 patients were entered onto treatment trials and 2,435 participants on cancer prevention and control trials in 1999. Cancer prevention and control research in the CCOPs is aimed at reducing cancer incidence, morbidity, and mortality through the identification, testing, and evaluation of interventions in controlled clinical trials. The development of cancer prevention and control research in the CCOP network has been increasing steadily since funding started in 1987. Protocols cover the full spectrum of cancer prevention and control research, from chemoprevention and the validation of biomarkers, screening and early detection, pain control and symptom management, and other rehabilitation and continuing care interventions. Several large chemoprevention trials have been implemented through the CCOP network, including the breast cancer prevention trial with tamoxifen (BCPT), ,the prostate cancer prevention trial with finasteride (PCPT), and the study of tamoxifen and raloxifene in the prevention of breast cancer (STAR). The CCOPs are a vital resource for conducting NCI cancer prevention and control research because they provide access to: 1) a national network for cancer prevention and control trials which require large sample sizes for completion; 2) geographic areas which include cross sections of the population, providing mixes of patients/participants not always available in university or urban settings; 3) large populations of cancer patients free of disease which provide a unique resource for chemoprevention clinical trials; and 4) cancer patients' family members and others who may be at increased risk of developing cancer and thus be candidates for prevention and detection studies. Participation in cancer prevention and control research by CCOPs also further expands the network of community physicians, increasing the potential for diffusion of state-of-the-art cancer prevention and control practices. Objectives and Scope The CCOP initiative is designed to: (1) Bring the advantages of state-of-the-art cancer treatment and prevention and control research to individuals in their own communities by having practicing physicians and their participants enter onto NCI-approved cancer treatment and prevention and control clinical trials; (2) Provide a basis for involving a wider segment of the community in cancer prevention and control research and investigate the impact of cancer therapy and control advances in community medical practices; (3) Increase the involvement of primary health care providers and other specialists (e.g., surgeons, family practitioners, urologists, gynecologists) with the CCOP investigators in cancer treatment and prevention and control research, providing an opportunity for education and exchange of information; (4) Facilitate wider community participation, including minorities, women and, other underserved populations, in cancer treatment and prevention and control research approved by NCI; and (5) Reduce cancer incidence, morbidity, and mortality by accelerating the transfer of newly developed cancer prevention, early detection, treatment, patient management, rehabilitation, and continuing care technology to widespread community application. Participating community programs (CCOPs) will be required to enter patients onto NCI-approved cancer treatment and prevention and control clinical trials through the research base(s) with which each CCOP is affiliated. CCOPs may relate directly to NCI for assistance and participation in selected cancer prevention and control protocols. CCOP performance will be evaluated on a continuing basis by the NCI program director. Participating research bases will be required to continue providing clinical treatment and/or cancer prevention and control research protocols, as applicable, and as studies progress and findings indicate, to develop new protocols. Cancer prevention and control research should be intervention- oriented and may include such areas as cancer prevention, early detection, symptom management, rehabilitation, quality of life, and continuing care. Research bases will be expected to monitor the quality of protocol conduct, follow CCOP accrual, and participate on a continuing basis in program evaluation. SPECIAL REQUIREMENTS Terms and Conditions of Award The administrative and funding instrument used for this program is a cooperative agreement (U10), an "assistance" mechanism (rather than an "acquisition" mechanism) 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 purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Program Staff. The following terms and conditions pertaining to the scope and nature of the interaction between NCI and the investigators will be incorporated in the Notice of Award. These terms will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. The terms and conditions 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 part 74; other HHS, PHS, and NIH Grant Administration policy statements; and other NCI administrative terms of award. A. Terms and Conditions of Award for CCOP Awardees 1. CCOP Awardees Responsibilities The awardee's programmatic responsibilities for the conduct of the research supported by this cooperative agreement are described in the following; the INVESTIGATOR'S HANDBOOK, a Manual for Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment and Diagnosis, (DCTD), National Cancer Institute and can be found at URL: http://ctep.cancer.gov/handbook; the NCI-CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES and can be found at URL: http://ctep.cancer.gov/monitoring/guidelines.html and any subsequent modifications of these documents; and the Intellectual Property Option to Collaborator that can be found at the URL address: http://ctep.cancer.gov/industry/ipo.html These documents are hereby incorporated by reference as terms of award and are available at the URLs cited above or from the program staff listed under “INQUIRES.” 1.a. Protocols All protocols originating from and/or coordinated by the research bases for CCOP use must be reviewed and approved by the Cancer Prevention and Control Protocol Review Committee (CPCPRC), Division of Cancer Prevention (DCP), and/or the Protocol Review Committee (PRC), Division of Cancer Treatment and Diagnosis (DCTD), NCI, prior to implementation. Protocols will be assigned credit once they are approved by the review committee. To be eligible to receive credit for accrual to a research base protocol, the CCOP must have an affiliation agreement with the research base responsible to NCI for that protocol. The research base is responsible for the development and implementation of high quality cancer treatment and prevention and control clinical trials, and for evaluation of the results of such studies. 1.b. Research Base Affiliation(s) Each CCOP must affiliate with one national multi-specialty cooperative group having a spectrum of cancer treatment and prevention and control clinical trials. Each CCOP can affiliate with a maximum of four additional research bases exclusive of the national mult-specialty cooperative groups (exceptions may be granted in conjunction with participation in an NCI sponsored "pilot" project). Note: A list of currently eligible research bases may be obtained from the following URL: http://dcp.nci.nih.gov/CORB/ or from the program official listed in the Letter of Intent Section. If participation in the protocols of one group competes with that of another group with which the CCOP is affiliated, the CCOP must prioritize the protocols in order to avoid bias in the allocation of patients to competing protocols. Initial affiliations should be maintained for the duration of the funding cycle. When circumstances require changes in research base affiliations, prior written approval from the DCP Program Director is required. 1.c. Accrual Each CCOP is required to accrue a minimum of 50 credits* per year to treatment clinical trials that have been approved by the PRC, DCTD, NCI. (The 50 credit minimum requirement may be waived for those applicants whose speciality is pediatrics and are able to place a majority of their eligible patients on protocols.) As one measure of performance, it is expected that at least 10 percent of patients for whom protocols are available will be placed on clinical trials by CCOP physicians. Each CCOP is required to accrue a minimum of 50 credits* per year to cancer prevention and control clinical trials that have been approved by the CPCPRC, DCP. The CCOPs ability to meet projected accrual goals to both cancer treatment and prevention and control clinical trials will be assessed. For CCOPs that have demonstrated an outstanding record of accrual to cancer prevention and control clinical trials, the 50 credit minimum for treatment may be waived. * Each protocol approved for CCOP use will be assigned a credit value. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow-up. For example, each patient accrued to an average Phase II or Phase III treatment protocol will count 1 credit; and an NCI-designated high-priority treatment protocol 1.5 credits. Cancer prevention and control protocols will be assessed for credit using a similar approach. For example, a randomized Phase III chemoprevention protocol will be assigned a value of 1 credit per participant entered. Cancer control protocols involving limited interventions will receive credit that is commensurate with the amount of data management effort required, usually an assignment of 0.3 or 0.5 credit per participant entered. Follow-up credit for chemoprevention protocols may also be assigned. In addition, CCOPs are encouraged to participate in cancer prevention and control research studies supported through other federal administrative and funding instruments such as research project grants (R01s) and contracts. 1.d. Quality Control The CCOP must establish and follow procedures for the assurance of data quality and quality control in accordance with research base guidelines and NCI policies. The CCOP must follow NCI-approved procedures developed by the research base for the prevention and/or identification of false or otherwise unreliable data and for quality assurance of data collected by the research base. The CCOP must follow policies developed by the research base and approved by the NCI for auditing the accuracy of scientific data submitted to them by the research base participants. 1.e. Data Management The CCOP must provide the DCP Program Director with access to all data generated under this award for periodic review of data management procedures of the CCOP. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the FDA, and with NCI's agreements with pharmaceutical companies for the co-development of investigational agents. The awardees will retain custody of and primary rights to their data. 1.f. Investigational Drug Management Investigators performing trials under cooperative agreements will be expected, in cooperation with NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. Specifically, all CCOP investigators must have an active NCI Investigator Number. 1.g. Organizational Changes Certain CCOP organizational changes must have the prior written approval of the DCP Program Director. These include the addition/deletion of a participating physician, a health professional other than a physician (who actively enters patients to cancer prevention and control trials), an affiliate, component, or research base. 1.h. Radiotherapy Equipment Radiotherapy equipment must have its calibration verified according to standards set by the Radiologic Physics Center (RPC) in order for institutions to participate in protocols requiring radiation therapy, as required by the affiliated research base(s). 1.i. Monitoring Each CCOP must agree to periodic on-site audits by representatives of its research base(s), NCI, or an NCI-designee. Such on-site audits may include review of the following: use of investigational drugs; compliance with regulations for Institutional Review Board (IRB) approval and informed consent (compliance with 45 CFR 46); compliance with protocol specifications; quality control and accuracy of data recording; and completeness of reporting adverse drug reactions. Reports of such on-site audits will be reviewed by the Clinical Trials Monitoring Branch (CTMB), Cancer Therapy Evaluation Program (CTEP), DCTD, and by the DCP Program Director. In addition, NCI program and grants management staff will review protocol accrual, fiscal and administrative procedures. CCOP members/affiliate performance sites and/or individual investigators participating or collaborating on NCI-supported multi-institutional clinical trials must be in compliance with the monitoring standards established by the research base. They should include the following standards: (1) Medical records submitted in support of NCI multi-institutional trials must conform to usual standards for the maintenance of clear, accurate, and unambiguous medical records. White-outs on medical records are unacceptable; (2) If it is the usual and customary practice of a department, laboratory, clinic or office to prepare or issue official reports, then only that department, laboratory, clinic or office can change the report, and alterations of the medical record must be initialed and dated by the person making such alterations. For clinical progress notes, the change must be dated and initialed by the person making the change. Only one line should be placed through the initial entry, so that both the original entry and the change are legible; (3) The improper modification of important patient records will result in additional investigations by the NCI Clinical Trials Monitoring Branch (CTMB) and may lead to suspension of accrual and funding. 1.j. Reporting Requirements Annual progress reports must be submitted to DCP. A suggested format developed by the DCP Program Director for this purpose will be provided. The inability of a CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 1.k. Network Participation CCOPs are part of a national network for conducting cancer treatment and prevention and control clinical trials. As such, each CCOP may be asked to participate in strategy sessions or workshops and in the continuing evaluation of the program and its impact in the community. 1.l. Patient/Participant Log Each CCOP may be asked to periodically maintain a new patient/participant log or minimal registry to include as applicable age, sex, race, insurance status, risk factors, primary site of cancer, stage of disease, and disposition for the potentially eligible patient/participant pool seen by the CCOP investigators. 1.m. Federally Mandated Regulatory Requirements Each CCOP must establish mechanisms to meet DHHS/PHS regulations for the protection of human subjects. At a minimum, these include: (1) methods for assuring that each facility at which CCOP investigators are conducting clinical trials has a current, approved assurance on file with the Office for Protection from Research Risks (OPRR); that each protocol is reviewed by the responsible IRB prior to patient entry; and that each protocol is reviewed annually by the IRB so long as the protocol is active; (2) methods for assuring or documenting that each patient (or patient's parent/legal guardian) gives fully informed written consent to participation in a research protocol prior to the initiation of the experimental intervention; (3) a system for assuring timely reporting of all serious and unexpected toxicities to the Investigational Drug Branch, CTEP, DCTD, according to DCTD guidelines and/or to DCP according to DCP guidelines; and (4) implementation of DCP/DCTD requirements for storage and accounting for investigational agents provided under DCP/DCTD sponsorship. 1.n. Publications Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgment of NCI support. 2. NCI Staff Involvement 2.a. Protocol Review All protocols originating from and/or coordinated by the research bases for CCOP use must be reviewed and approved by the Cancer Prevention and Control Protocol Review Committee (CPCPRC), Division of Cancer Prevention (DCP), and/or the Protocol Review Committee (PRC), Division of Cancer Treatment and Diagnosis (DCTD), NCI, prior to implementation. Protocols will be assigned credit once they are approved by the review committee. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a protocol that has not been approved, or that has been closed (except for patients already on study). 2.b. Monitoring There will be periodic on-site audits of each CCOP by representatives of its research base(s), NCI, or an NCI-designee, such as DCTD's current Clinical Trials Monitoring Service contractor. The DCP and CTMB/CTEP will review and provide advice regarding mechanisms established for study monitoring including the on-site auditing program. DCP/CTEP and/or its contractor staff may attend the on-site audits conducted by the Research Base or its NCI designee as observers. 2.c. Data Management The DCP Program Director will have access to all data generated under this award and will periodically review the data management procedures of the CCOP. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the Food and Drug Administration (FDA). 2.d. Investigational Drug Management The Regulatory Affairs Branch (RAB), Pharmaceutical Management Branch (PMB), CTEP, DCTD and the Chemopreventive Agent Development Research Group, DCP will advise investigators of specific requirements and changes in requirements about investigational drug management that the FDA and NCI may mandate. 2.e. Organizational Changes The DCP program director will review requests for certain organizational changes and provide written approval. These changes include the addition/deletion of a participating physician or other health professional entering patients/participants in cancer prevention and control research in the CCOP, an affiliate, component, or research base. 2.f. Program Review The DCP program director will review the annual progress report submitted by each CCOP. A suggested format will be developed by the DCP Program Director for this purpose. The DCP Program Director will review the progress of each CCOP through consideration of the CCOP annual report, program site visits, and reports from affiliated research bases. This review may include, but not be limited to, overall accrual credits, percent of available patients/participants placed on study, eligibility and evaluability of individuals entered on study, and timeliness and quality of data reporting. The inability of a CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 2.g. Strategy Sessions The DCP Program Director or designee will sponsor strategy sessions when indicated, attended by principal investigators from the CCOPs and appropriate DCP/DCTD staff. At these meetings, information relevant to the CCOPs will be reviewed and discussed, including such issues as overall CCOP performance and the science of current or proposed clinical trials. Data will be analyzed and the outstanding research questions established and prioritized into national research goals by CCOP investigators and the DCP/DCTD attendees. The principal investigators will have the primary responsibility for analyzing and prioritizing the research questions to be developed into clinical trials. The DCP Program Director will also assist the CCOP investigators in exploring mutual interests in cancer prevention and control research. 2.h. Federally Mandated Regulatory Requirements The DCP Program Director or designee and DCTD staff will review mechanisms established by each CCOP to meet the Department of Health and Human Services (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. 2.i. Arbitration Process The Terms and Conditions of Award require that the DCP Program Director make post-award administrative decisions related to program performance, programmatic decisions on scientific-technical matters, and funding adjustments. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the DCP Program Director. An arbitration panel (with appropriate expertise) composed of one member of the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend a course of action to the Director, DCP. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations at 45 CFR Part 16. B. Terms and Conditions of Award for Research Base Awardees 1. Research Base Awardees Responsibilities It is the responsibility of the Research Base in accordance with its constitution, bylaws, policies and procedures to develop the details of the research design, including definition of objectives and approaches, planning, implementation, analysis, and publication of results, interpretations and conclusions of studies. The research base shall designate research base investigators to serve as Protocol Chairpersons for each proposed study. Protocols will be developed in accordance with the instructions in the INVESTIGATOR'S HANDBOOK available at the following URL: http://ctep.cancer.gov/handbook or from the program staff listed under INQUIRES. 1.a. Protocol Development The research base is responsible for the development and implementation of high quality cancer treatment and prevention and control clinical trials, and for evaluation of the results of such clinical trials. The protocol should be a document mutually acceptable to the research base and to DCP/DCTD. Communication at the various stages of development is encouraged. 1.b. Concept/Protocol Submission All research base protocols utilized by the CCOPs must be reviewed and approved for CCOP use by the Cancer Prevention and Control Protocol Review Committee, (CPCPRC) DCP, and/or the Protocol Review Committee (PRC), DCTD, NCI, prior to implementation. Treatment and cancer prevention and control protocols should be submitted to the Protocol Information Office (PIO), CTEP, DCTD for review by the appropriate committee. All cancer prevention and control protocols must be preceded by the submission of a concept proposal for review by the DCP Cancer Prevention and Control Concept Review Committee (CPCCRC). The CPCCRC considers scientific merit and the feasibility of implementing prospective cancer control protocols in the CCOP research network. Similarly, concept proposals for cancer treatment protocols must precede protocol development. Cancer treatment concepts are reviewed by the CTEP Protocol Review Committee (PRC) in the DCTD. All concept and protocol documents should be submitted to the PIO, CTEP, DCTD. DCTD may also require a letter of intent for new cancer treatment trials. 1.c. Accrual A research base for treatment research is required to accrue a minimum of 50 credits* per year from affiliated CCOPs to treatment clinical trials that have been approved by the PRC, DCTD, NCI. During the initial funding period, a research base is required to develop sufficient affiliations to accrue 50 cancer treatment credits by the end of the third year. A research base for cancer prevention and control research is required to accrue a minimum of 50 credits* per year from CCOPs, members and other affiliates to cancer prevention and control clinical trials that have been approved by the CPCPRC, DCP. During the initial funding period, a research base is required to develop cancer prevention and control protocols to allow accrual of 50 cancer control credits by the end of the third year. * Each protocol approved for CCOP use will be assigned a credit value. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow-up. For example, each patient accrued to an average Phase II or Phase III treatment protocol will count 1 credit; and an NCI-designated high-priority treatment protocol 1.5 credits. Cancer prevention and control protocols will be assessed for credit using a similar approach. For example, a randomized Phase III chemoprevention protocol will be assigned a value of 1 credit per participant entered. An additional 0.3 credits may be assigned for chemoprevention trials requiring multiple years of follow-up. Cancer control protocols involving limited interventions will receive credit that is commensurate with the amount of data management effort required. In addition, research bases are encouraged to broaden their research efforts in cancer prevention and control by participation in studies supported through other federal administrative and funding mechanisms such as research project grants (R01s) and contracts. 1.d. Data Management and Analysis The research base shall establish and implement mechanisms for data management and analysis that ensure that data collection and management procedures are: (a) adequate for quality control and analysis; (b) as simple as is appropriate in order to encourage maximum participation of physicians entering patients and to avoid unnecessary expense; and (c) sufficiently uniform across research bases. CCOP members/affiliate performance sites are required to follow procedures for data management and analysis. Data generated are the property of the awardee; however, the research base must provide DCP/DCTD with access to all data generated under this award. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the FDA and by NCI's agreements with pharmaceutical companies for the co-development of investigational agents. 1.e. Quality Control A DCP/DCTD-funded research base must follow all the policies and procedures for quality control established by NCI. Similar policies and procedures for quality control will be expected from cancer centers. The research bases shall establish mechanisms for quality control of all procedures and modalities employed in its trials. CCOP member/affiliates are required to follow research base procedures for quality control. The research base shall establish mechanisms for study monitoring. CCOP Members/Affiliates are required to follow the awardee procedures for study monitoring. The research base is responsible for assuring accurate and timely knowledge of the progress of each study through: (1) tracking and reporting of patient accrual and adherence to defined accrual goals; (2) ongoing assessment of case eligibility and evaluability; (3) timely medical review and assessment of patient data; (4) Medical records used in support of NCI multi-institutional trials must conform to usual standard for the maintenance of clear, accurate, and unambiguous medical records. White-outs on medical records are unacceptable; (5) rapid reporting of treatment-related morbidity and measures to ensure communication of this information to all parties; (6) interim evaluation and consideration of measures of outcome as consistent with patient safety and good clinical trials practice; (7) timely communication of results of studies; and (8) an on-site monitoring program. The research base is responsible for ensuring that all performance sites have routine audits which are reported to the NCI in accordance with the NCI/CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES. Guidelines are available at the following URL: http://ctep.cancer.gov/handbook. In the event that the NCI determines that the awardee failed to comply with these guidelines, the accrual of new patients/participants to the research base's protocols at the affected performance site shall be suspended immediately upon notice of the NCI determination. The suspension will remain in effect until the awardee conducts the required audit and the audit report is accepted by the NCI. The research base will be responsible for notifying any affected performance site of the suspension. During the suspension period, no funds from this award may be provided to the performance site for new accruals, and no changes to the award for new accruals will be permitted. The NCI will also notify an institution that is the direct recipient of a cooperative agreement from the NCI if it is necessary to suspend accrual at that institution. 1.f. Quality Assurance of Data The research base must develop and follow procedures for the assurance of data quality and quality control in accordance with research base guidelines and NCI policies. The research base must follow NCI-approved procedures for the prevention and/or identification of false or otherwise unreliable data and for quality assurance of data collected. The research base must develop and implement NCI-approved policies for auditing the accuracy of scientific data submitted to them. In the event that there is a finding through the quality assurance and/or quality control programs of any indication of a pattern of non-compliance with protocol or regulatory requirements or a finding of possible alteration of data, these findings must be reported in accordance with the NCI-CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES. Guidelines are available at the following URL: http://ctep.cancer.gov/handbook 1.g. Data and Safety Monitoring Committees The research base must establish and maintain Data and Safety Monitoring Committees (DSMCs) for all Phase III clinical trials in accordance with the NCI policy for Data Safety and Monitoring of Clinical Trials. The NCI policy may be found at URL: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. The research base must comply with the approved policies and procedures of the DSMB. 1.h. Protocol Closure The research base shall establish a mechanism for interim monitoring of results and monitoring protocol progress. If the research base wishes to close accrual to a study prior to meeting the initially established accrual goal, the interim results and other documentation should be made available to NCI staff for review and concurrence prior to closure. It is recommended that statistical guidelines for early closure be presented as explicitly as possible in the protocol in order to facilitate these decisions. In the event that the DSMC has recommended early closure, DSMC procedures regarding notification of DCP must be followed. 1.i. Protocol Reporting Requirements Reporting requirements will be in agreement with FDA regulations and NCI procedures. Interim reports of each activated and ongoing study shall appear in the minutes of each research base meeting and shall include specific data on patient/participant accrual as well as, when appropriate, detailed reports of treatment-associated morbidity. Quarterly accrual reports must be provided as appropriate to CTEP for all active studies. A system for providing such information in a timely manner should be in place. 1.j. Annual Progress Report Annual progress reports, including an annual performance report on each affiliated CCOP, must be submitted to DCP. A suggested format developed by the DCP Program Director for this purpose will be provided. The DCP Program Director will review the performance of each research base. The annual report will include, at a minimum, information on: overall case accrual credits; cancer prevention and control research, existing or planned; eligibility and evaluability of patients/participants entered on study; timeliness and quality of data reporting; and results of quality control review and audits if performed during that year. Research base funding is contingent on accrual from affiliated CCOPs/Minority- Based CCOPs and annual adjustments may be made. The inability of a research base to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA or significant changes in the level of performance may result in an adjustment of funding, withholding of support, suspension or termination of the award. 1.k. Adverse Event Procedures In order to be in compliance with FDA regulations, all recipients of NCI support for clinical trials, including research bases responsible for coordinating and monitoring such trials, must promptly report adverse events (including adverse drug reactions) to the NCI and any other trial sponsors according to directions provided in the adverse event reporting section of the INVESTIGATOR'S HANDBOOK available at the following URL: http://ctep.cancer.gov/handbook The awardee will notify all institutions/investigators participating in this project, funded or unfunded, about the above requirement and about the institutions'/investigators' responsibility to report adverse events as specified in the protocol. The awardee will also notify the Investigational Drug Branch (IDB),CTEP, DCTD Drug Monitor for DCTD-sponsored investigational agents and the Program Director for other agents, of serious or life- threatening events, as specified in the protocol. 1.l. Performance Review The research base shall establish policies and procedures for credentialing participating CCOPS and conducting periodic review of the performance and membership status of each performance site conducting prevention and control clinical trials. This review should examine scientific contributions, patient accrual, data accuracy and timeliness, protocol compliance, and audit results. 1.m. Data Files Available to NCI Upon Request Upon the request of the Grants Management Officer, NCI, copies of data files and supporting documentation for all NCI-supported protocols that have a major impact on patterns of care, as determined by the NCI, shall be made available to the NCI in a timely manner. 1.n. Investigational Drug Management Investigators performing trials under cooperative agreements will be expected, in cooperation with DCP/DCTD to comply with all FDA distribution, monitoring, and reporting requirements for investigational agents. 1.o. Network Participation Research bases are part of a national network for conducting cancer treatment and prevention and control clinical trials. As such, each research base may be asked to participate in strategy sessions or workshops and the continuing evaluation of the program and its impact in the community. 1.p. Federally Mandated Regulatory Requirements Each research base must establish mechanisms to meet FDA regulatory requirements for clinical trials involving DCP/DCTD-sponsored investigational agents and DHHS/PHS regulations for the protection of human subjects. These regulations include but are not limited to Title 21 CFR 50, 56 and 312 and Title 45 CFR 46. At a minimum the research base must be able to: (1) demonstrate that each participant has a current approved assurance on file with the NIH Office for Protection from Research Risks (OPRR); (2) demonstrate that each protocol and informed consent is approved by the responsible Institutional Review Board (IRB) prior to patient entry, that each investigator has a current FDA Form 1572 and curriculum vitae on file with the Pharmaceutical Management Branch, (PMB), CTEP; (3) demonstrate that each patient (or legal representative) gives written informed consent prior to entry on study; (4) implement the CTEP requirement for storage and accounting for investigational agents provided under DCP/DCTD sponsorship; (5) establish an on-site audit program for periodic data verification and review of regulatory responsibilities at each CCOP, cooperative group member, cooperative group affiliate program, and cancer center affiliate institution; (6) provide a method, upon DCP/DCTD request, of summarizing efficacy and toxicity data to be included in DCP/DCTD's annual reports to the FDA for each investigational agent; (7) establish a method for the timely reporting of all serious and unexpected toxicities. 1.q. CCOPS/Minority-Based CCOPs Research bases must agree to affiliate with CCOPs/Minority-Based CCOPs when they are funded, according to guidelines established by each research base for its affiliates, and as appropriate. 1.r. Publications Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgment of NCI support. 1.s. Procedures in the Event of Scientific Misconduct If a duly authorized governmental or institutional body issues a final determination that scientific misconduct has occurred or if the awardee determines that other events have occurred which have significantly affected the quality or integrity of the Group data or patient safety, the awardee is responsible for notifying the Group Data and Safety Monitoring Committee (DSMC), the CTMB, the collaborating investigators, the appropriate Institutional Review Boards (IRBs), and other sponsors of the affected work. The awardee is also responsible, if the events described above have occurred, for ensuring that submitted but unpublished abstracts and manuscripts are corrected, if possible. If publication deadlines have passed or if abstracts and/or manuscripts containing the affected data have already been published, the awardee is responsible, within 90 days after learning of the event(s) significantly affecting the quality of the Group data or patient safety, for submitting to NCI a re-analysis of the results deleting the false or otherwise unreliable data, and disclosing within the text the reason(s) for the re- analysis. The awardee must submit the re-analysis for publication. The NCI may disseminate information about the re-analysis as broadly as it deems necessary. The awardee must use its best efforts to notify all scientists, research laboratories, and other organizations to which the awardee has sent research materials affected by false or otherwise unreliable data. True copies of data files and other supporting documentation from studies affected by scientific misconduct or other findings affecting the quality or integrity of data or patient safety shall be made available to the NCI in a timely manner upon the request of the Grants Management Officer, NCI. The NCI reserves the right to re-analyze, to publish, or to distribute its analyses of these data when it is in the interest of public health. Prior to release, publication or distribution of such analyses, the NCI will provide such analyses to the awardee. 1.t. Notification of Patients by the Awardee During Patient's Lifetime In order for there to be an appropriate response in the event the NCI determines, either while a protocol is active or (if relevant) during the lifetime of the participants following protocol closure, that a medically important toxicity or side effect is associated with protocol-directed treatment or that the medical care of one or more participants may have been compromised by scientific misconduct or other finding affecting the integrity of the data or patient safety at the awardee institution or at a third-party institution, funded or unfunded, the awardee shall assure that the institution(s) responsible for these participant(s') accrual, whether funded or unfunded, will have procedures in place to: (a) contact each participant individually at his or her last known address on file with the institution and give each participant contacted appropriate information and the right to communicate with an appropriate institutional representative and, in the event of misconduct, to meet with a physician not connected with the clinical trial or study in which the participant has participated; and (b) encourage participants to notify the institution of any changes of address. The procedure must provide for informing the participants fully of the consequences of the toxicity or misconduct for their care and well-being, if any, and the availability of follow-up; and their opportunity to examine any portion of their medical records relevant to the potential effect of the toxicity or side effect upon them or that may be affected by scientific misconduct or other findings affecting the quality or integrity of the data or patient safety. It is understood that under regulations at 45 CFR Section 74.53, NCI has a right of access to research records pertinent to the NCI funding. In exceptional circumstances, such as a public health emergency, the institutions will be required to provide participant names and treatments to the NCI in a format which allows direct notification of the patient by the NCI. 2. NCI Staff Involvement 2.a. Scientific Resource The Division of Cancer Prevention (DCP) and Division of Cancer Treatment and Diagnosis (DCTD) staff will serve as a resource for specific scientific information on cancer prevention and control clinical trials, treatment regimens, and clinical trial design. The DCP Program Director will assist the research base as appropriate in developing information concerning the scientific basis for specific trials and will also be responsible for advising the research base of the nature and results of relevant trials being carried out nationally or internationally. The DCP Program Director will sponsor strategy sessions when indicated, attended by leading investigators from the research bases, other extramural scientists, and appropriate experts to discuss specific research initiatives. The Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program (CTEP), DCTD, and the Chemopreventive Agent Development Research Group, DCP, through the DCP Program Director, will provide updated information on the efficacy, toxicity and availability of all Investigational New Drugs (INDs) supplied by NCI to the research base. 2.b. Protocol Development The protocol is a document mutually acceptable to the research base and to DCP/DCTD. Communication at the various stages of development is encouraged. DCP/DCTD staff will assist the research base in protocol design as appropriate by providing information regarding: a) the existence and nature of concurrent clinical trials in the area of research, with an emphasis on preventing duplication of effort; b) relevant pharmacokinetic and pharmacodynamic data on investigational agents; c) availability of investigational agents, including biologic response modifiers; d) feasibility and appropriateness of the research for use by the CCOPs and/or in a community setting; and e) basic research in cancer centers and other NCI-funded programs which may be ready for clinical trials. DCP/DCTD will also comment on the scientific rationale, programmatic relevance, priority, design, statistical requirements, and implementation of the proposed study. 2.c. Concept/Protocol Review All research base protocols utilized by the CCOPs must be reviewed and approved for CCOP use by the Cancer Prevention and Control Protocol Review Committee, (CPCPRC) DCP, NCI and/or the Protocol Review Committee (PRC), DCTD, NCI, prior to implementation. The major considerations in protocol review by DCP or DCTD include; a) strength of the scientific rationale supporting the study; b) importance of the question being proposed; c) avoidance of undesirable duplication with ongoing clinical trials; d) appropriateness and feasibility of study design; e) satisfactory projected accrual rate and follow-up period; f) patient/participant safety; g) compliance with NIH and the federal regulatory requirements; h) adequacy of data management; and i) appropriateness of patient/participant selection, evaluation, assessment of toxicity, response to intervention, and follow-up. The DCP/DCTD review committee chairperson will provide the research base with a consensus review that describes recommended modifications and other suggestions as appropriate. If a protocol is disapproved, reasons will be communicated to the research base principal investigator as a consensus review within a reasonable time. The DCP Program Director will work with the research base, where appropriate, to develop a mutually acceptable protocol compatible with the research interests, abilities, and needs of the base, its affiliates, and NCI. Credit will be assigned following final approval of the protocol. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a protocol that has not been approved. 2.d. Data Management and Analysis The awardees will retain custody of and primary rights to their data; however, DCP/DCTD will have access to all data generated under this award. The DCP Program Director or a DCTD representative may review data management and analysis procedures of the research base, under mutually agreeable circumstances, for consistency with policies and procedures established by DCP/DCTD for awardees conducting cancer treatment and prevention and control clinical trials. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the Food and Drug Administration (FDA) and by NCI's agreements with pharmaceutical companies for the co-development of investigational agents. 2.e. Quality Control and Monitoring The Clinical Trials Monitoring Branch (CTMB), CTEP, DCTD/DCP Program Director may review quality control and monitoring procedures of the research base including the on-site auditing program for consistency with policies and procedures established by DCTD/DCP for awardees conducting cancer treatment and prevention and control clinical trials. 2.f. Review of Quality Control and Study Monitoring The DCP and CTMB, CTEP will review and provide advice regarding mechanisms established for study monitoring including the on-site auditing program. DCP/CTEP and/or its contractor staff may attend as observers, the on-site audits conducted by the Research Base or its NCI designee. The frequency of participation by an NCI representative as observer will be determined by the NCI. 2.g. Data and Safety Monitoring Committees The NCI Staff will assess the research base compliance with NCI established policies on Data and Safety Monitoring Committees for Phase III trials. One or more DCP/CTEP staff will serve as non-voting members on the DSMC. 2.h. Investigational Drug Management The Regulatory Affairs Branch, CTEP, DCTD, and the Chemoprevention Branch, CPRP, DCP, staff will advise investigators of specific requirements and changes in requirements concerning investigational drug management that the FDA may mandate. 2.i. Program Review Annual progress reports, including an annual performance report on each affiliated CCOP, must be submitted to DCP. DCP staff will provide a suggested format for this purpose. The DCP Program Director will review the progress of each research base through consideration of the research base quarterly accrual reports, annual report and program site visits. The DCP program director will make funding recommendations based on accrual from affiliated CCOPs/Minority-Based CCOPs and annual adjustments in funding may be made. The inability of a research base to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 2.j. Protocol Closure DCP/DCTD will review research base mechanisms for interim monitoring of results and will monitor protocol progress. DCP/DCTD may request that a protocol study be closed for reasons including: a) insufficient accrual rate; b) accrual goal met; c) poor protocol performance; d) patient/participant safety; e) already conclusive study results; and f) emergence of new information which diminishes the scientific importance of the study question. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a study after requesting closure (except for patients already on study). 2.k. Federally Mandated Regulatory Requirements The DCP Program Director and a DCTD representative will review mechanisms established by each research base to meet Department of Health and Human Services (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. 2.l. CCOPs/Minority-Based CCOPs The DCP Program Director will notify research bases when CCOPs/Minority-Based CCOPs are funded. 2.m. Arbitration Process The Terms and Conditions of Award require that the DCP Program Director make post-award decisions related to protocol review, program performance and adjustments in funding. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and NCI staff. An arbitration panel (with appropriate expertise) composed of one member of the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend an appropriate course of action to the Director, DCP. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. STUDY POPULATIONS 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 sub populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide For Grants and Contracts, Volume 23, Number 11, March 18, 1994. Internet address is as follows: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. Investigators may also obtain copies of the policy from the program staff listed under "INQUIRIES". Program staff may also provide additional relevant information concerning the policy. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type 1and Type 2) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. As part of the scientific and technical merit evaluation of the research plan, reviewers will be instructed to address the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. Issues related to the implementation of this policy should be referred to the Director, OEP, OER (301/435-2768). Note: Applicants for National Cancer Institute funding who propose clinical research for adults with cancer may use language similar to the following for the "Participation of Children" section of their application: This CCOP project does not include children because the number of children with cancer is limited and because the majority are already accessed by a nationwide pediatric cancer research network. This exemption is based on Exclusion 4b of the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects. LETTER OF INTENT Prospective applicants are asked to submit, by June 9, 2000, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent should be sent to the program staff listed under INQUIRIES. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Preparation of Application The research grant application form PHS-398 (rev. 4/98) is to be used in applying for cooperative agreements. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD, 20892-7910, telephone number (301) 435-0714, e-mail: grantsinfo@nih.gov. For those applicants with internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm. A suggested format will be sent to all applicants requesting an RFA or submitting a letter of intent. All applicants are encouraged to obtain and use the suggested format instructions for organizing the specific information concerning the RFA programmatic requirements in the PHS 398. If tables from the "Suggestions for Organizing Information for a CCOP Application" are included, those tables should be part of the body of the application, and NOT included in the appendix. Also, responses to the instructions concerning "Human Subjects" verification must be included in the application at the time of submission. 1. CCOP Applicants Because the Terms and Conditions of Award (discussed in the SPECIAL REQUIREMENTS Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. An application from a currently funded program will be a competing continuation and must include a progress report, which at a minimum consists of: (1) a summary of prior CCOP activities/accomplishments, including a clear presentation of annual accrual over the funding period. Accrual tables from previous annual progress reports should be included. A summary of accrual to all cancer treatment and a summary of accrual to all cancer prevention and control protocols by gender and ethnicity must be provided; progress in meeting DCP's established accrual goals must be presented; (2) a plan for continuing to meet prevention and control accrual requirements including plans for follow-up of participants from the large prevention trials as well as plans for implementation of additional cancer control protocols; (3) tables of the current budget and FTEs with a justification for any request for additional resources; (4) an evaluation of CCOP performance by affiliated research base(s); and (5) a complete description of how the applicant has met the special cooperative agreement terms and conditions of the award. For ALL Applicants: 1.a. Each applicant must delineate its catchment area. A map of the service area, designating counties or zip codes from which approximately 80 percent of the patients will be drawn, should be provided. A description of other cancer care resources in the catchment area (i.e., hospitals, clinics, physicians, cancer centers) which are not part of the application should be included. In describing the study population, a breakdown by percentage of the gender and minority composition of the study population should be provided. This information may be based on the institutional records and/or prior experience. 1.b. Each applicant must demonstrate the potential and stated commitment to accrue a minimum of 50 credits per year to treatment clinical trials (except if waived for applicants whose specialty is pediatrics or those with an outstanding record in cancer prevention and control accrual). Documentation must include any prior participation in treatment research clinical trials with a clear presentation of the total number of patients and credits accrued to NCI-approved treatment clinical trials. A list of the NCI approved treatment protocols in which the applicant expects to participate and the projected accrual to each must be provided. Plans for recruiting women and minority participants must be included. 1.c. Each applicant must demonstrate the potential and plans for accrual of a minimum of 50 credits per year to cancer prevention and control protocols. Documentation must include any prior participation in cancer prevention and control research clinical trials with a clear presentation of the total number of patients and credits accrued to NCI approved cancer prevention and control clinical trials. A list of the NCI approved prevention and control protocols in which the applicant expects to participate and the projected accrual must be provided. Plans for recruiting women and minority participants must be included. If applicable, CCOP applicants should describe their participation in cancer prevention and control research supported by other federal administrative and funding instruments (e.g., research projects grants (R01s), contracts). For NEW Applicants: New applicants must provide implementation plans for at least two examples of NCI-approved cancer prevention and control protocols that utilize an intervention. The applicant should describe their plan for implementation, including specifics on patient/participant recruitment, compliance and follow- up. These studies must come from research bases with which they propose to affiliate. The CCOP applicant must document the ability to access the appropriate physicians and patient/participant populations, and adequate facilities to participate in the proposed clinical trials. 1.d. A designated Principal Investigator is required. An associate principal investigator also should be named to assure continuity in the event of resignation of the principal investigator. The qualifications and experience of both, in terms of ability to organize and manage a community oncology program that includes cancer treatment and prevention and control research and related activities, as well as experience in accruing patients/participants to treatment and cancer prevention and control clinical trials must be described. 1.e. Each applicant is expected to have a committed multidisciplinary professional group appropriate for its expected protocol participation. This team may include medical oncologists, surgeons, radiation oncologists, pathologists, oncology nurses, data managers, health educators, and other disciplines (e.g., gynecology, urology, pediatrics, internal medicine, family practice) as appropriate. The training and experience of participating physicians must be provided, along with a description of working relationships. Any experience working together as a group, particularly in implementing clinical cancer treatment and prevention and control research and related activities, should be included. An organizational chart showing how the group will function must also be included. 1.f. Each applicant must provide the qualifications and experience of all proposed support personnel as well as a description of the proposed duties for each position. 1.g. Through formal affiliations with only one multi-specialty cooperative group (exceptions may be granted in conjunction with participation in an NCI sponsored "pilot" project) and up to four additional research bases, each applicant must demonstrate access to both cancer treatment and prevention and control research protocols. Evidence must be provided that an affiliation has been established with one NCI-approved multi-specialty cooperative group. In addition, affiliations with research bases offering only cancer prevention and control protocols are appropriate. The conditions of affiliation must be provided in the CCOP-research base affiliation agreement(s). Initial affiliations should be maintained during the funding cycle. Multiple research base affiliations are permitted provided they are not conflicting. The affiliation agreements must state specifically how the problem of competing protocols will be resolved. Note: A list of currently eligible research bases may be obtained from the following URL: http://dcp.nci.nih.gov/CORB/ or from the program official listed in the Letter of Intent Section. 1.h. Quality control procedures must be described in detail. Assurance of quality is the joint responsibility of the CCOP and its research base(s). Quality control procedures of the research base will be applied to the CCOPs and should be specified in the CCOP-research base affiliation agreement. Procedures for investigational drug monitoring and data management must also be described. 1.i. The availability of facilities, including laboratories, inpatient and outpatient resources, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization and/or documentation of consortium arrangements must be provided. Evidence of involvement with community-based voluntary organizations may be submitted. In addition, each applicant must have a defined space for administrative activities and administrative personnel which will serve as a focus for data management, quality control, and communication. 1.j. Allocation of funds to support community costs for receipt, handling, and quality control of patient data must be specified. Allowable items in the budget are requests for full or part-time administrative personnel, clinical research associates, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., reimbursement of patient care expenses; transportation costs). Funding is not allowed for clinical support personnel (e.g. pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on CCOP organizational/administrative tasks. Justification must be provided for personnel time, effort and funds requested. 2. RESEARCH BASE Applicants Because the Terms and Conditions of Award (discussed in the Special Requirements Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. An application from a currently funded research base will be a competing continuation and must include a progress report, which at a minimum consists of: 1) a summary of prior research base activities/accomplishments, including a clear presentation of annual accrual to cancer treatment and annual accrual to cancer prevention and control protocols (gender and racial/ethnic minority composition) from affiliated CCOPs over the funding period; 2) progress in developing and implementing a cancer prevention and control research program. Include the process and organizational structure for protocol development and implementation, selection and evaluation (auditing) of performance sites, data management, quality control, statistical analysis, and study safety monitoring; 3) a clear presentation of annual accrual to each NCI-approved prevention and control clinical trial for CCOPs, and research base members and affiliates; (4) status of concepts and protocols under development; (5) a description of how the applicant has met the special cooperative agreement terms and conditions of the award. Cooperative groups must participate in both cancer treatment and prevention and control clinical trials; cancer centers may participate in cancer treatment and prevention and control clinical trials or cancer prevention and control research only. In describing the study population, it is required that a description of the gender and minority population and subpopulation served be provided, as well as an outreach plan. This information may be based on the institutional records and/or prior experience. 2.a. Each applicant must demonstrate the ability to design and implement multi-institutional treatment clinical trials (if applicable). A list of treatment protocols available for CCOP participation must be provided. 2.b. Each applicant must demonstrate the ability to design and implement multi-institutional cancer prevention and control clinical trials. A list of cancer prevention and control protocols available for CCOP participation must be provided. New research base applicants must also provide at least two examples of active or proposed cancer prevention and control intervention clinical trials and describe plans for study design, intervention(s), and statistical considerations; access to potential patients/participants to be studied; and procedures for data management, quality control, and follow-up. The availability of appropriate expertise to design, implement, and analyze the results of the proposed clinical trials must be documented. 2.c. Each applicant must have an organizational structure for involving appropriate personnel in the design and implementation of treatment and/or cancer prevention and control research. An organizational chart and a description of the research base operations showing the relationship(s) between the scientific and administrative functional units of the research base, vis-a-vis the conduct of treatment and/or cancer prevention and control clinical trials, must be provided. The organizational focus within the research base for cancer prevention and control research must be described, including the composition and activities of the research base cancer prevention and control committee, or equivalent, and its relationship to other clinical trial committees and activities. 2.d. Collaboration with affiliated CCOPs/Minority-Based CCOPs in treatment and/or cancer prevention and control research, as applicable, is required. CCOP-research base affiliation agreements must be included in the application. For treatment research, each applicant must demonstrate the ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to treatment clinical trials. During the initial funding period a research base must demonstrate that they have developed sufficient CCOP affiliations to accrue a minimum of 50 cancer treatment credits by the end of the third year. For cancer prevention and control research, each applicant must demonstrate the ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs, members and other affiliates to cancer prevention and control clinical trials. During the initial funding period a research base must develop cancer prevention and control protocols to allow accrual of a minimum of 50 cancer prevention and control credits by the end of the third year. If applicable, CCOP research base applicants should describe their participation in cancer prevention and control research studies supported by other federal administrative and funding mechanisms such as research project grants (R01s ) and contracts. It is expected that selected cooperative group members, affiliate programs and/or cancer center affiliates other than the CCOPs will participate in cancer prevention and control research. Research Base applications can include requests for non-CCOP member institutions to become "prevention members." The Research Base applicants must describe the experience and contribution of the non-CCOP member institution to the science and accrual to cancer chemoprevention clinical trials. The applicant must indicate the participants and their expected level of participation, and describe their ability to participate. 2.e. A designated Principal Investigator is required and his/her qualifications and experience must be described. An individual must be designated to coordinate cancer prevention and control research. His or her qualifications and experience within the research base structure should also be described. Each applicant must also demonstrate the ability to access professionals with the appropriate expertise to design and implement the proposed treatment and/or cancer prevention and control clinical trials. Basic scientists, medical, surgical, radiation and other oncology specialists, nurse oncologists, epidemiologists, health educators and/or other public health professionals may be included. 2.f. Each applicant's ability to manage the data from multi-institutional treatment and/or cancer prevention and control clinical trials must be described. Data management includes development of data collection forms, procedures for data transmittal, procedures for data entry, data editing, compilation, and analysis, as well as procedures for quality control and verification of submitted data. Standards should exist for determining eligibility and evaluability of patients/participants entered on protocols. Statistical capability must exist to develop protocol statistical parameters, analyze the data, and report results. 2.g. Each applicant must demonstrate the ability to initiate procedures for training and maintaining the proficiency of personnel from affiliated CCOPs/Minority-Based CCOPs on techniques for successful management of treatment and/or cancer prevention and control clinical trials research. Depending on the clinical trials initiated and the interventions involved, this will include training for data managers/nurses and any other individuals responsible for data collection, monitoring, or carrying out the intervention(s). 2.h. Each applicant's ability to provide mechanisms for periodic review of the performance of affiliated CCOPs/Minority-Based CCOPs, including on-site monitoring (auditing) and written procedures and criteria for continued affiliations, must be described. Similar measures must be described for other member/affiliates participating in cancer prevention and control research. 2.i. Each applicant must describe its plan for independent data and safety monitoring for all phase III prevention and control clinical trials. 2.j. Requests for funds must reflect operations/statistical costs for quality control and data management costs for CCOP participation in protocols. This estimate is based on the expected accrual credits of affiliated CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer prevention and control. CCOP-research base affiliation agreements must be included. Each applicant should include a budget for monitoring and auditing activities. Funding can be requested for scientific development and pilot testing of new cancer prevention and control research initiatives (including support of a cancer prevention and control committee for the research base), and funds can also be requested for appropriate travel to meetings directly related to study activities (such as NCI-sponsored strategy sessions/workshops). In addition, the Research Bases may request funding for specific non-CCOP member institutions that apply to become "prevention members." A detailed budget for each prevention member must be included in the application. Specific justification for all requested funds must also be included in the application. Method of Applying The RFA label available in the PHS-398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three (3) signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive Room 1040 - MSC 7710 Bethesda, Maryland 20892-7710 (20817 for courier service) Photocopies must be clear and single-sided. At the time of submission, two (2) additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062, MSC-8239 Rockville, Maryland 20852 (for courier service) Bethesda, Maryland 20892-8239 It is important to send these copies at the same time that the original and three copies are sent to CSR; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received on or before the designated receipt date. Applications must be received by July 14, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS A. REVIEW PROCEDURES Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the NCI staff. Incomplete and/or non-responsive applications will be returned to the applicant without 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 in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. B. REVIEW CRITERIA 1. CCOP Applicants All applicants will be evaluated on the following criteria: 1.a. Adequacy of plans to include both genders and minorities and their subgroups. Plans for the recruitment and retention of participants will also be evaluated. In describing the study population, it is required that a description of the gender and minority population and subpopulation served be provided, as well as an outreach plan. This information may be based on the institutional records and/or prior experience. 1.b. Ability to accrue a minimum of 50 credits per year to treatment clinical trials and a minimum of 50 credits per year to cancer prevention and control clinical trials. Established CCOPs will be funded at a yearly accrual goal that may be higher than 50 credits for treatment clinical trials and 50 credits for cancer prevention and control clinical trials. These established CCOPs will be evaluated for their past performance in meeting these accrual goals. The minimum treatment accrual requirement may be waived for applicants whose specialty is pediatrics, or for applicants with an outstanding record in prevention and control. Each applicant's ability to access the appropriate populations, professional disciplines, and facilities to participate with affiliated research bases in NCI-approved cancer prevention and control intervention protocols will be appraised. Any prior participation in cancer treatment and prevention and control research will be considered. For new CCOP applicants, the plans for implementing at least two NCI-approved protocols will be assessed for feasibility and practicality. In addition, participation in cancer prevention and control research studies supported through other federal and administrative funding instruments such as research project grants (R01s) and contracts will be evaluated. 1.c. Qualifications and experience of the principal investigator/associate principal investigator, in terms of ability to organize and manage a community oncology program that includes both cancer treatment and prevention and control research as well as accrual to such protocols, and related activities. 1.d. Training, experience, and commitment of participating physicians for accruing individuals to protocols in which the applicant has agreed to participate. The experience of proposed investigators in the entry and treatment of cancer patients on research trials (gained from residency, fellowships, postdoctoral training and/or subsequent practice) will be appraised. For multidisciplinary studies, evidence of the availability of appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, gynecology, urology, pathology, internal medicine, family practice, nursing, and nutrition) will be required. Experience or special skills in cancer prevention and control research and related activities will be considered, together with availability of other community resources and personnel for such clinical trials. 1.e. Stability of the functional unit or group applying to become a CCOP. Preexisting organizational affiliations of at least a core of the group applying, and evidence of stable working relationships, will be appraised. Examples of established consortium arrangements, and committee structure which demonstrates the participation of appropriate physicians and administrators, may be submitted. Evidence of previous success as a group in implementing clinical cancer treatment and prevention and control research and related activities will be considered. 1.f. Qualifications and experience of all proposed support personnel relative to their position descriptions. The relevant credentials and expected contributions to the program of personnel resources not fiscally supported by the award will be considered. 1.g. Adequacy of quality assurance mechanisms for both cancer treatment and prevention and control interventions, and adequacy of procedures for investigational drug monitoring and data management and identification of false or otherwise unreliable data. 1.h. Adequacy of available facilities, including laboratories, in-patient and outpatient resources, cancer registries, etc., and adequacy of space for administrative activities and personnel. 1.i. Appropriateness of research base affiliations and of the cancer treatment and prevention and control research protocols chosen. Affiliation agreements must be provided in the application. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Allowable items in the budget are requests for full or part-time administrative personnel, clinical research associates, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., patient care reimbursement, transportation costs). Funding is not allowed for clinical support personnel (e.g. pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on CCOP organizational/administrative tasks. Justification must be provided for personnel time and effort and funds requested. The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. For competing continuations, the review group will critically examine the adequacy of progress during the funding period, including ability to meet the accrual goals in cancer treatment and prevention and control, progress made as a CCOP, and evaluation of CCOP performance by affiliated research bases(s). Consideration will be given to previous accrual and the ability to meet the previous accrual projections for which the CCOP was funded. The research base evaluation report(s) must be provided in the application. Plans for continued accrual and follow-up of participants on protocols will be evaluated. 2. Research Base Applicants All research base applicants will be evaluated on the following criteria: 2.a. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of participants will also be evaluated. In describing the study population, it is required that a description of the gender and minority population and subpopulation served be provided, as well as an outreach plan. This information may be based on the institutional records and/or prior experience. 2.b. Experience in conducting multi-institutional clinical trials; demonstrated ability to develop such studies and act as a coordinating and statistical center; adequate facilities to conduct the clinical trials; adequate procedures to collect, monitor, and analyze the data and assure the safety of patients/participants. 2.c. Quality and availability of cancer treatment and/or prevention and control protocols, as applicable, which are appropriate for CCOP participation, or the potential for developing such clinical trials. For new applications, a detailed description of at least two examples of actual or planned cancer prevention and control protocols, with professional expertise to assure the quality of the proposed intervention clinical trial will be evaluated. 2.d. The ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to treatment clinical trials. The ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs, members and other affiliates to cancer prevention and control clinical trials. Experience as well as the potential for developing future clinical trials will be considered. Note: The minimum of 50 credits per year may be waived for a research base that expands the use of the CCOP network to cancer prevention and control trials supported through other federally funded mechanisms. These trials must have been approved by the CPCPRC, DCP for CCOP use. Because the data management for such trials is supported by another federally funded mechanism, the research base is not eligible to claim credit for accruals through the CCOPs/Minority-Based CCOPs, members and other affiliates. In addition, research base applicants= participation in and accrual to cancer prevention and control studies supported through other federal administrative and funding instruments such as research projects grants (R01s) and contracts will be reviewed and evaluated. Documentation must include CCOP-research base affiliation agreements. 2.e. Organizational structure for involving appropriate personnel in the design and implementation of treatment and/or cancer prevention and control research. The organizational focus within the research base for cancer prevention and control research, including the composition and activities of the cancer prevention and control committee, and the designation of protocol chairpersons and its relationship to other clinical trial committees and activities will be assessed. 2.f. Qualifications and experience of the principal investigator and/or the individual responsible for directly relating to the CCOPs. The availability and experience of multidisciplinary health professionals and allied professionals with skills needed to develop, utilize, and analyze treatment and/or cancer prevention and control clinical trials will also be evaluated. The qualifications and contribution to the science and accrual of cancer chemoprevention clinical trials will be assessed in the evaluation of the Research Base's request for the non-CCOP member institutions that apply for the designation of "prevention member". 2.g. Experience in working with community oncologists, orienting community data management personnel to protocol requirements, organizing scientific and educational meetings for those participating in the clinical trials, and participating in intergroup clinical trials. 2.h. Ability to establish quality control, quality assurance, and data management procedures. Experience in data management and analysis of multi- institutional clinical trials and adequacy of data management staff will be appraised. The use of mechanisms for periodic review of quality control, quality assurance, and data management procedures, safety monitoring, including procedures for data safety and monitoring committee and on-site auditing program will be assessed. 2.i. For competitive continuations, adequacy of progress in implementing a prevention and control clinical trials program including cancer prevention and control protocol development and implementation, accrual, data management, evaluation of performance sites; current status of each protocol and progress towards meeting planned accrual goals from CCOPs and members/affiliates; summary of prior activities with a clear presentation of annual accrual; completion of clinical trials, interim analyses, publication of findings, or other dissemination of trial findings throughout the research base; and other progress in meeting the requirements for a CCOP research base. During the initial funding period, a research base must demonstrate the adequacy of progress in implementing a cancer prevention and control clinical trials program that will result in attainment of accrual goals by the end of the third year. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Requests for funds must reflect operations/statistical costs for quality control and data management costs for CCOP participation in protocols. This estimate is based on the expected accrual credits of affiliated CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer prevention and control. Research bases should include a budget for monitoring and auditing costs. Funding may be requested for scientific development and pilot testing of new cancer prevention and control research initiatives, other costs related to implementation of specific cancer prevention and control protocols (including support of a cancer prevention and control committee for the research base), or for appropriate travel to meetings directly related to study activities (such as NCI-sponsored strategy sessions/workshops). Additionally, funding may be requested to provide infrastructure support for non-CCOP member institutions of the Research Bases that can show significant contribution to the science and/or accrual for chemoprevention trials. Specific justification must be provided. The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA The anticipated date of award is June 1, 2001. Applications recommended by the National Cancer Advisory Board will be considered by NCI staff for award based upon (a) scientific and technical merit; (b) demographic and geographic distribution of applicants to assure inclusion of minority and underserved population; (c) availability of funds. Multiple CCOP applicants for funding who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. SCHEDULE Letter of Intent Receipt: June 9, 2000 Application Receipt Date: July 14, 2000 Review by NCAB Advisory Board: February 2001 Anticipated Award Date: June 1, 2001 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: Joseph Kelaghan, MD Acting Chief, Community Oncology and Prevention Trials Research Group Division of Cancer Prevention, NCI Executive Plaza North - Room 300 6130 Executive Boulevard, MSC-7340 Bethesda, Maryland 20892-7340 Telephone: (301) 496-8541 Fax: (301) 496-8667 E-mail address: jk85i@nih.gov Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062, MSC-8239 Rockville, Maryland 20852 (for courier service) Bethesda, Maryland 20892-8239 Telephone: (301) 496-3428 Fax: (301) 496-0275 Email address: tf12w@nih.gov Direct inquiries regarding fiscal matters to: Ms. Crystal Wolfrey Grants Administration Branch Office of the Director, NCI Executive Plaza South - Room 243 6120 Executive Boulevard Bethesda, Maryland 20892 Telephone: (301) 496-7800 Fax: (301) 496-8601 E-mail: crystal.wolfrey@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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