National Cancer Institute, Research Contracts Branch, ESS, Executive Plaza South, Rm. 620, 6120 Executive Blvd., MSC 7224, Bethesda, MD 20892-7224

B -- POLYP PREVENTION TRIAL -- CONTINUED FOLLOW-UP STUDY SOL RFP N02-SC-91009-21 DUE 111698 POC Barbara A.. Shadrick, Contracting Officer; phone 301 435-3787; fax 301 480-0241 WEB: Acquisition Management Branch, Current Requests for, http://amb.nci.nih.gov/rfp.htm. E-MAIL: Barbara Shadrick, bs927@nih.gov. ELECTRONIC RFP ANNOUNCEMENT. THIS RFP MAY BE ACCESSED THROUGH THE ACQUISITION MANAGEMENT BRANCH (AMB) HOME PAGE AT http://amb.nci.nih.gov/RFP.htm THIS RFP WILL NOT BE AVAILABLE AT THIS WEB SITE UNTIL ON/ABOUT OCTOBER 14, 1998. INTERESTED OFFERORS ARE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. IT IS THE OFFEROR'S RESPONSIBILITY TO MONITOR THE INTERNET SITE FOR THE RELEASE OF THIS SOLICITATION AND AMENDMENTS, IF ANY. The Cancer Prevention Studies Branch (CPSB), Division of Clinical Sciences (DCS) and the Nutrition Epidemiology Branch (NEB), Division of Cancer Epidemiology and Genetics (DCEG) of the National Cancer Institute (NCI), National Institutes of Health (NIH), are jointly funding a proposed contract for the Polyp Prevention Trial Continued Follow-up Study (PPT/CFS) which involves low-cost, reduced-scale, post-intervention observation of the participants in the NCI PPT, a randomized dietary intervention trial with 2079 participants. In the PPT/CFS, the NCI will ascertain adenoma recurrence in the PPT participants for an additional five years. There will be no active dietary intervention. The PPT is a randomized, controlled trial which was carried out at eight Clinical Centers in the United States. Under the proposed acquisition, the Data and Nutrition Coordinating Center (DNCC) shall be responsible for two major areas of this study: 1) data collection and 2) data management. The DNCC shall develop and maintain systems and procedures needed for biomedical data management, be responsible for obtaining data directly from participants and medical records, tracking data collection and data analysis. The DNCC shall be required to interact with NCI staff on a daily basis (this capability must be demonstrated in any subsequent proposal as a mandatory requirement for an acceptable proposal). Senior NCI staff with expertise in study and data management will oversee all parts of this study and will work closely with the Contractor in the proper execution of this acquisition. STUDY OBJECTIVES include follow-up of PPT participants, obtaining self-administered questionnaire information, obtaining clinical and pathology reports and hospitalization and death certificate information and comparing the adenoma recurrent rates in the intervention and control groups. No biologic specimens shall be obtained during this continued follow-up phase of the study. SPECIFIC TASKS include data collection, data management, data entry, development and maintenance of a data management system, development and maintenance of computer systems for data management and statistical analysis, quality assurance, data storage, reports, provision of biological specimen storage and shipping, delivery service, general support and study closure. COMPUTER SYSTEMS REQUIREMENTS include review, editing and entering of data collected during the study into a data base, maintenance and storage under project initials of all data sets. The Contractor shall use the NIH Division of Computer Research and Technology (DCRT) time-sharing system. These consist of a large IBM 370 series facility and a DEC 10 time-sharing system. These systems are commonly referred to as the "DCRT" systems. The Contractor shall use, to the extent possible, general purpose software from the NIH/DCRT program library. The Contractor shall provide the necessary equipment and software for all work on this contract. A controlled and secure environment for source documents and specimens shall be provided. Backups should be stored outside of DCRT. The Contractor shall adhere to the Epidemiologic and Biometric Studies of the NIH, HHS/NIH/OD, Privacy Act System of Records requirement (95-25-0200) as described in the Federal Register, Volume 62, No. 66, April 7, 1997. NOTE: The NIH/DCRT facility is located at 9000 Rockville Pike, Bethesda, Maryland; the current DCS offices are located 6130 Executive Boulevard, Rockville, Maryland. It is anticipated that the proposed contract will be a cost-reimbursement, completion type contract for a five-year period of performance. All responsible sources capable of providing this support and meeting these criteria are encouraged to submit an offer and will be considered by the NCI. Point of contact: Barbara A. Shadrick; Electronic mail address: bs92y@nih.gov; Fax: 301-480-0241. No collect calls will be accepted. Posted 10/08/98 (W-SN260595). (0281)

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