Full Text CA-93-05 RESEARCH AND DEVELOPMENT PROJECTS IN CHEMOPREVENTION NIH GUIDE, Volume 21, Number 42, November 20, 1992 RFA: CA-93-05 P.T. 34 Keywords: Chemoprevention Cancer/Carcinogenesis National Cancer Institute Letter of Intent Receipt Date: December 9, 1992 Application Receipt Date: February 9, 1993 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications for cooperative agreements to encourage coordinated submissions of projects from investigators dedicated to developmental research in chemoprevention. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Research and Development Projects in Chemoprevention, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Each application will be considered on its own merit as an individual research project. Applicants for Research and Development Projects (RDPs) in Chemoprevention MAY NOT concurrently submit R01 applications that represent significant duplication of the efforts described in the applicant's RDP. MECHANISM OF SUPPORT This RFA will use the cooperative agreement mechanism (U01). The cooperative agreement is an assistance mechanism in which substantial NIH programmatic involvement with the recipient during performance of the planned activity is anticipated. The nature of the Program Director's involvement is described in the section on Special Requirements, D.1. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant/awardee. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. This RFA is a one-time solicitation. Future unsolicited competitive continuation applications will compete with all other investigator-initiated research applications and be peer reviewed by a study section in the Division of Research Grants (DRG), NIH. However, if it is determined that there is a sufficient continuing need, the NCI will invite recipients of awards made in FY 93 under this RFA to submit competitive continuing applications for review according to procedures described below in the APPLICATION PROCEDURES and REVIEW CONSIDERATIONS sections. An assistance relationship will exist between NCI and the awardees to accomplish the purpose of the activity. As more fully described later in this announcement, the recipients will have primary responsibility for the development and performance of the activity. However, there will be government involvement with regard to (1) assistance in securing an Investigational New Drug (IND) approval from the Food and Drug Administration (FDA), (2) coordination and assistance in obtaining the chemopreventive agent, (3) monitoring of safety and toxicity and, (4) quality assurance of the clinical chemistry aspects of the study. Awards will not be made until all arrangements for obtaining the IND and the agent are completed. Final awards will also consider not only the cost of the clinical trial but also the cost of the agent and, if necessary, its formulation. The anticipated direct cost will be in the range of $150,000 to $250,000. FUNDS AVAILABLE Approximately $4.0 million in total costs for the first year for project periods up to five years will be committed to specifically fund applications which are submitted in response to this RFA. It is anticipated that 9 to 15 awards will be made. This number of awards is dependent on the receipt of a sufficient number of applications of high scientific merit. The earliest feasible start date for the initial awards will be December, 1993. Although this program is provided for in the financial plans of the NCI, awards made pursuant to this RFA will be contingent upon the continued availability of funds for this purpose. RESEARCH OBJECTIVES Background This RFA encourages submissions of applications from investigators wanting to conduct collaborative translational research in cancer chemoprevention. Translational research moves the results of basic research studies in the laboratory or developmental studies to clinical research in human subjects or populations. The research objectives of these projects should be the development of intermediate biomarkers of cancer risk and evaluation of the efficacy of individual biological and/or molecular markers as intermediate endpoints in chemoprevention trials. Candidate chemical, biological, molecular, and dietary cancer chemopreventive agents have been identified from in vivo studies in animal model systems and epidemiological studies. The efficacy of each of these agents individually or in concert in modulating cancer risk can best be evaluated through prevention clinical trials. Limitations of the usefulness of such trials is the long duration and large sample populations generally needed to achieve statistical significance. This limitation could be overcome by identification of biological or molecular markers suitable for use as intermediate endpoints in the process of carcinogenesis. Ideally, such markers would be expressed in an abnormal form in tumor tissue or washings or in serum of high-risk individuals, but revert to the normal form when exposed to the chemopreventive agent. Our evolving understanding of the molecular biology of carcinogenesis has identified possible oncogene and suppressor gene candidates and molecular alterations in these candidates, and their interactions with other cellular components, that could serve as intermediate markers in cancer chemoprevention trials. Examples would include sequential genetic alterations in oncogenes HER-2/neu, C-myc, c-abl; in tumor suppressors RB, p53 and APC; markers for increased risk for cancer (Li-Fraumeni-p53, NF-1, APC, and early onset 17q21); and interactions between oncogenes, suppressor genes and the cyclin P34 complex. New developments in the understanding of cellular function and metabolites have provided information on possible candidate markers for cell growth, proliferation, differentiation, and neoplastic transformation. Included among these candidates are abnormal cytology, nuclear aberrations (micronuclei), ornithine decarboxylase and/or prostaglandins synthetase, DNA ploidy, and colonic mucosal proliferation. Cancer chemoprevention trials responsive to this RFA will examine modulation of candidate markers in response to administration of chemopreventive agents. Additionally, these markers could be used to identify human populations at high risk for cancer, and therefore useful as sample populations for these trials. SPECIAL REQUIREMENTS A. General This RFA represents a single competition, with a specified deadline, February 9, 1993, for receipt of applications. It is expected that each application will describe plans for a mixture of basic, developmental, and clinical research from an investigator wanting to focus on a particular study in cancer chemoprevention. Each submission should have a general focus on study outcomes and the application of basic research and development to human subjects and populations. If not contained within the investigator's own research project, plans should be cited for establishing contacts with investigators with complementary interests that would fulfill the broader goals of translational chemoprevention studies. B. Special Emphasis The studies described should be developed with preclinical and clinical phases that may include a pilot phase in humans that could later proceed to a full scale intervention. One or more intermediate endpoints might be initially evaluated to determine baseline parameters and subsequently to serve as a follow-up after the administration of the preventive measure or the chemopreventive agent in vivo and/or in vitro. The main emphasis should be on small, efficient studies aimed at improving future research designs, providing a molecular basis for the action of the chemopreventive agent(s), or providing improved intermediate endpoint biomarkers. After successful completion of the pilot phase (i.e., demonstrated modulation of endpoint markers), subsequent studies could include a clinical trial monitoring the test system, a cancer incidence or mortality endpoint, and a designated agent. Studies that develop and evaluate new technologies for identification of new genes, gene products, and DNA probes to identify human disease and individuals at high risk or predisposition to cancer are encouraged. For the initial human phase, the proposed study might describe the relevance of the marker test system to clinical or public health cancer prevention, the rationale for the selection of the study population, and potential intervention agent or procedure. The project could result later in the markers and agent being evaluated in a full scale, double-blind, randomized, risk reduction clinical trial. C. Terms of Cooperation The special award terms and conditions as described in section C.1-2 below will be incorporated in the Notice of Grant Award and are in addition to, and not in lieu of, otherwise applicable HHS Administrative Regulations at 45 CFR 74; other DHHS, PHS and NIH Grant Administration Policy Statements and other NCI administrative terms of award. 1. Program Staff Involvement a. Study/Protocol Plan The NCI Program Director (cited in the LETTER OF INTENT section below) will assist the awardees in the study and protocol design by providing information regarding a) the nature of concurrent studies in the area of research, pointing out possible duplication of effort, b) availability of necessary drugs. The NCI Program Director will also offer advice regarding the scientific rationale, priority, design, and implementation of the proposed studies. A safety and protocol review will be undertaken by the NCI Program Director on all clinical trials from proposals which are ultimately funded. Such a review is legally required by the FDA to assure that all safety, toxicity, monitoring, and reporting issues are in conformance with Investigational New Drug guidelines. The awardee institutions and Principal Investigator must agree to comply with the recommendations of the review. b. Data Access The NCI Program Director will have access to the data to review toxicity and safety aspects of the project, prepare IND applications and monitor any trial aspects required by other federal agencies. This information is necessary to satisfy FDA regulations with regard to Code of Federal Regulations (CFR) 21. The awardees, however, will retain custody of and primary rights to their data. The NCI Program Director may encourage and facilitate sharing of data between investigators when this is in the mutual interest of the investigators and the NCI. c. Investigational New Drug (IND) The NCI will have the option to cross file or independently file an IND on investigational drugs evaluated in trials supported under the cooperative agreements. The NCI will advise investigators of specific requirements and changes in requirements concerning investigational drug management for compliance with NCI and the FDA guidelines and regulations. Investigators conducting trials under cooperative agreements will be expected, in cooperation with the NCI, to comply with all FDA monitoring and reporting requirements for investigational agents, for reporting adverse reactions, and for maintaining necessary records of drug receipt and distribution. d. Assistance with Obtaining or Purchasing Investigational Drugs The NCI Program Director will assist the investigator to obtain the agent to be used in the proposed study. Once the application is recommended for funding by the peer review committee, the NCI, and the National Cancer Advisory Board, the NCI Program Director may begin discussions with the principal investigators and pharmaceutical industry with regard to obtaining the drug. In the event a suitable agent is not available at no cost, the NCI may proceed to purchase the agent through normal procurement mechanisms. Purchase of the agents is only undertaken after measures to obtain the drug at no cost have been exhausted. Awards will not be made until all arrangements for obtaining the agent are complete. Final awards by the NCI will also consider not only the cost of the trial but also the cost of the agent, including its formulation, encapsulation and packaging, if these costs are to be borne by the Government. e. Protocol Modification No protocol modifications will be implemented without approval from the NCI Program Director, consistent with FDA requirements. f. Protocol Termination The NCI Program Director may request that a protocol study be terminated. Reasons for this request may be: (a) insufficient accrual, (b) further accrual will not add information of scientific value, and/or (c) consideration of patient safety. The NCI will not provide drugs or IND sponsorship for a study after requesting termination. Investigators who wish to challenge protocol termination may do so according to the arbitration process described below. In addition, the NCI may withdraw funding for such a protocol if the grounds for termination are patient safety and toxicity. The Arbitration Mechanism is described in g. below. g. Description of Arbitration Mechanism When mutually acceptable agreements on the safety of research protocols, protocol disapproval or protocol termination cannot be obtained between investigators and the NCI Program Director, as described above, an arbitration panel will be formed composed of one award recipient designee, one NCI designee, and a third designee with appropriate expertise chosen by the other two members of the panel. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. h. Clinical Trials Progress Review Progress will be evaluated semi-annually by the NCI Program Director from material presented in the awardee's semi-annual report (as described below). Recommendations of the NCI Program Director will be communicated by letter to the investigator to which he/she is expected to respond. Insufficient numbers of patients accrued to attain the stated delta value (d=difference between treatments to be detected divided by standard deviation), unsatisfactory progress, or non-compliance with terms of award may result in a reduction of the budget, withholding of support, suspension or termination of the award. i. Quality Assurance (1) The NCI has established a clinical chemistry quality assurance program with the National Institutes of Standards and Technology, Gaithersburg, Maryland which will provide chemical standards for some of the agents that will be used and assayed for in the clinical trials. These standards will contribute to the quality control of selected laboratory determinations. The awardee will participate in the laboratory quality control activity when so notified. (2) Periodically, the NCI Program Director will review the mechanisms established by each awardee for quality control of clinical studies. These mechanism must conform with FDA regulations. j. Other Terms No patients may be enrolled in this study without the prior written approval of the NCI Program Director for this cooperative agreement. Such approval is contingent upon submission to and approval by the FDA of an IND application and satisfactory response to the recommendations of the safety and protocol review. 2. Responsibilities of Awardees Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant/awardee. a. Safety and Toxicity Review Each awardee institution and principal investigator agree to comply with the recommendations of the safety and protocol review to assure that all FDA requirements are satisfied. b. Quality Control and Adverse Reaction Reporting (1) The awardee will be required by the NCI Program Director to set up mechanisms for quality control. Some or all of the following may be relevant: compliance with protocol requirements for eligibility; treatment and follow-up; laboratory data; dietary data; pathological materials; and operative reports. (2) The awardee agrees to perform the study according to the approved protocol. Any proposed changes in the protocol must receive the advance permission of the NCI Program Director for this award. (3) The awardee is required to conform to NCI guidelines for the use of investigational drugs including investigator registration (FDA Form 1573), maintaining a record of drug receipt and reporting of adverse drug reactions. Life threatening or unexpected toxicity MUST be reported by the investigator IMMEDIATELY by telephone to the NCI Program Director shown on the Notice of Grant Award and confirmed with details in writing within two weeks. The investigator will be responsible for amending protocols and consent forms based on new toxicity information sent to the investigators by NCI staff. c. Data Management and Reporting Requirements Data acquisition and analysis is the responsibility of the investigator. Each awardee institution will retain custody and primary rights to their data developed under these Cooperative Agreements. Investigators will be required to submit reports to the NCI using the following schedule and format as required by FDA Investigational Drug Regulations, CFR 21 312.23. (1) Semi-annual Reports Semi-annual scientific reports should report on the progress of the project during the previous six months and the cumulative progress of the study. (a) Individual Study Information. The summary is required to include the following information for each study: o The title of the study (with any appropriate study identifiers such as protocol number), its purpose, a brief statement identifying the patient population and the inclusion of women and minorities, and a statement as to whether the study is completed. o The total number of subjects initially planned for inclusion in the study, the number entered into the study to date, the number whose participation in the study was completed as planned, and the number who dropped out of the study for any reason. o If the study has been completed, or if interim results are known, a brief description of the study results. (b) Summary Information. Information obtained during the previous six months' clinical and nonclinical investigations, including: o A narrative or tabular summary showing the most frequent and most serious adverse experiences by body system. o A list of subjects who died during participation in the investigation, with the cause of death for each subject. o A list of subjects who dropped out during the course of the investigation in association with any adverse experience, whether or not thought to be drug related. o A brief description of what, if anything, was obtained that is pertinent to an understanding of the drug's actions, including for example, information about dose response, information from controlled trials, and information about bioavailability. o A list of the preclinical studies (including animal studies) completed or in progress during the past year and a summary of the major preclinical findings. (c) A description of the general investigational plan for the coming year to replace that submitted one year earlier. (d) A description of any significant pilot trial protocol modifications made during the previous year and not previously reported to the IND in a protocol amendment. (e) A brief summary of significant foreign marketing developments with the drug during the past year, such as approval of marketing in any country or withdrawal or suspension from marketing in any country. Due Dates for Reports January 1 and July 1 for the semiannual report. (2) Final Study Report The final report of a completed study shall consist of detailed analyses of results and toxicity, plans for publications, a comprehensive list of all previous publications related to the project, and plans for archiving and storing the study records. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research dosing and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by December 9, 1992, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is to be sent to: Marjorie Perloff, M.D. Program Director, Chemoprevention Branch National Cancer Institute Executive Plaza North, Suite 201 Bethesda, MD 20892-4200 Telephone: (301) 496-8563 FAX: (301) 402-0553 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these cooperative agreements. These forms are available at institutional sponsored research or business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Room 449, Westwood Building, 5333 Westbard Avenue Bethesda, Maryland 20892; and from the NCI Program Director named above. The RFA label available in the PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the title of the application, Research and Development Projects in Chemoprevention, and the RFA number, CA-93-05, must be typed in block 2a of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, clear, single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent to: Referral Officer Division of Extramural Activities National Cancer Institute Room 848, Westwood Building 5333 Westbard Avenue Bethesda, MD 20892 If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, and has been or has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. Preparation of the Application The general instructions for preparation of the applications contained in the grant application form PHS 398 (rev. 9/91) are to be used in preparing cooperative agreement applications. Because of the award terms and conditions included in the section under SPECIAL REQUIREMENTS, C. Terms of Cooperation, it is important that applicants indicate in the Research Plan how they will meet the requirements stated in the RFA for staff involvement. To ensure that the cooperative agreement remains the appropriate instrument, awardees submitting competing continuation and supplemental applications must describe how they have met the established terms and conditions. The following items apply to new as well as to competing continuation applications: 1. The study should clearly address a pilot trial and optionally a definitive trial. The pilot trial must involve the application of a biological and/or biochemical marker and its modulation by the study agent. The definitive trial involves the implementation of a full scale randomized, double-blind, risk reduction, prevention clinical trial. For applicants seeking to conduct only a pilot trial, the study must describe relevance to a clinical trial application including a marker, agent, and target group that might be appropriate for a full scale intervention after completion of the pilot study. 2. The applicant should provide a rationale for selection of the biological or biochemical marker, its relevance to risk identification or modulation, and its relevance to the intervention agent and the target population. 3. The applicant should provide the rationale for selection of the proposed intervention agent. This should include relevant epidemiologic and laboratory data. Preclinical and clinical data on any potential untoward effects of the intervention agent should also be presented. In circumstances where there might be some doubt as to the availability or the safety of the agent, the applicant may wish to consult with the pharmaceutical company and the NCI Program Director prior to preparing the application. The applicant should thus present a reasonable case for the "readiness" of the proposed intervention agent for a clinical trial. 4. The applicant should provide a rationale for selection of a specific target group and provide an estimate of the number of participants required for the completion of the study. Criteria and calculations used to estimate sample size should be included. The applicant should provide a description of the target population or group chosen and should justify the selection of this group. The group should be defined, as appropriate, by age, sex, race, dietary customs, education, geographic location, occupational or life style risk factors, and relevancy to a specific cancer problem or to its possible prevention by the designated inhibitor(s). The accrual rate should be estimated. If multiple institutions are involved, the proposal should include verification of the coinvestigators' willingness to participate, and pertinent additional information regarding the cooperating institutions' staff qualifications, resources, research plans, including patient availability and data flow, as well as corresponding budget requirements. 5. The applicant should clearly indicate the clinical chemistry and biologic aspects of the study to include collection, storage, handling, analysis, and quality control of biological or biochemical samples. The methods and equipment to be used and the technical qualifications and experience of the personnel involved must be addressed. If these aspects of the study are to be conducted by groups other than at the applicant's institution, a letter from the cooperating institutions indicating their willingness to participate should be included. 6. The applicant should elucidate any known or potential safety or toxicity considerations, the techniques and procedures to monitor and report any adverse health effects and appropriate dose modifications based on toxicity monitoring. 7. The applicant should specify the methods to be used to document nutrient intake, if indicated, and adherence to the prescribed intervention during the course of the trial. 8. The applicant must indicate a willingness to work cooperatively with the assistance of the NCI Program Director in the implementation and conduct of the study. 9. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. 10. Availability of the chemopreventive agents or dietary factors. REVIEW CONSIDERATIONS A. Review Procedure Upon receipt, applications will be administratively reviewed (initially) by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NCI program staff function. Applications will be judged to determine if they meet the goals and objectives of the program as described in the RFA. Applications that are judged non-responsive will be returned, but may be submitted for investigator initiated grant competition at the next receipt date. Questions concerning the relevance of proposed research to the RFA may be directed to the NCI Program Director. If the number of applications is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to identify those that are clearly not competitive for awards. Those applications judged to be both competitive and responsive will be further evaluated, using the review criteria shown below, for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. B. Review Criteria The following factors will be considered in evaluating the scientific merit of each response to the RFA: 1. Scientific merit of the study objective(s), design, and methodology to include considerations of toxicity, safety and quality assurance. 2. Basic and clinical scientific significance as well as originality of the proposed research. 3. Research experience and/or competence of the Principal Investigator and other key personnel to conduct the proposed studies. 4. Adequacy of time (effort) which the Principal Investigator and staff would devote to conduct the proposed studies. 5. Relevancy and appropriateness of the specific target population along with assurance as to its accessibility. 6. Identity of sources of data, tissues, fluids, and other materials procedures for their collection and analysis, and assurances of their accessibility. 7. Adequacy of plans for NCI program staff involvement with the proposed studies. 8. Adequacy of plan for inclusion of women and minorities The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each meritorious application. AWARD CRITERIA The earliest feasible start date for the initial awards will be December 1, 1993. In addition to the technical merit of the applications, NCI will consider how well the applicant institutions meet the goals and objectives of the program as described in the RFA, availability of resources, and study populations. 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 Dr. Perloff at the address listed under LETTER OF INTENT. Direct inquiries regarding fiscal matters to: Ms. Eileen Natoli Division of Cancer Prevention and Control Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Ext. 56 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control. Awards will be made under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410,; 42 U.S.C. 241, and Section 412, as amended by Public Law 99-158, 42 U.S.C. 258a-1); and administered under PHS grants policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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