National Cancer Institute, Research Contracts Branch, PCPSS, Executive Plaza South, Room 635, Bethesda, Md 20892

A -- PHASE II CLINICAL STUDIES OF NEW CHEMOPREVENTIVE AGENTS SOL 85077-57 DUE 101500 POC Desiree E. Sylver-Foust WEB: N01-CN-85077-57 Phase II Clinical Studies of, http://rcb-inter.nci.nih.gov/appl/rfp/85077/Table%20of%20Contents.htm. E-MAIL: Desiree E. Sylver-Foust, Desiree_Foust@nih.gov. ELECTRONIC RFP ANNOUNCEMENT: POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS.) The Division of Cancer Prevention (DCP), National Cancer Institute (NCI), National Institute of Health (NIH), intends to expand the existing Master Agreement (MA) pool for "Phase II Clinical Trials of New Chemopreventive Agents". Offerors selected for award of a MA may be solicited to provide the adequate capabilities and technical expertise to furnish all necessary services, qualified personnel, materials and supplies and facilities to carry out the objective of this MA which is to encourage cancer chemoprevention clinical trials that use biochemical and biological markers as intermediate endpoints. The application of biological markers to clinical prevention trials carries great promise in relation to ultimate cancer prevention. When cancer incidence reduction itself is used as an endpoint in studies of this type, a very large number of subjects tested for long durations is often required. The design of phase 2a clinical trials will be small, short-term, efficient studies that determine the dose-response of a given chemopreventive agent on pharmacological and intermediate endpoints, the minimum dose at which this biological effect is observed, and the maximum safe dose. The second segment phase 2b study will involve a randomized, placebo- controlled, blinded trial in a small group of subjects in which the endpoint will be a modulation of a quantifiable biological effect that is correlated with cancer incidence reduction in the agent versus the placebo treated groups. Master Agreements will be awarded to all respondents whose technical proposal is considered acceptable. The Master Agreement award is non-monetary and is exclusively for the purpose of compiling a pool of contractors who are pre-qualified to perform services to perform specific Phase II studies. Each Master Agreement holder will be eligible to compete for future contract awards to carry out specific Phase II studies. Master Agreement holders receiving a contract award will be selected through this pool, based on technical merit and on budgetary considerations for specific tasks involved. Any MA awarded as a result of this solicitation will be in effect from the effective date to October 30, 2002. (This solicitation will be open for the duration of the existing MA Pool with due dates for receipt of proposals annually, October 15 (or the next business day) of each year.) All responsible sources meeting these criteria are encouraged to submit a proposal and a sample requirement to be considered by the NCI. ALL MA HOLDERS ALREADY IN THE EXISTING MA POOL NEED NOT RESPOND TO THIS ANNOUNCEMENT. The RFP may be accessed through the Research Contracts Branch Home Page by using the following Internet address: http://amb.nci.nih.gov/ under "Current Request for Proposals." It is the offeror''s responsibility to monitor the above internet site for the release of this solicitation and amendments, if any. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. (Hard copies will be available only upon individual request). Point of contact: Desiree Sylver-Foust, Contract Specialist, NCI, RCB, PCPSS; 6120 Executive Boulevard, Executive Plaza South, Room 635, Rockville, MD 20852; Email address: ds154o@nih.gov.; Telephone: (301) 435-3833; Fax (301) 402-8579. All requests should reference the RFP No. N01-CN-85077-57. No collect calls will be accepted. Posted 08/14/00 (W-SN485550). (0227)

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