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COMMERCE BUSINESS DAILY ISSUE OF OCTOBER 6,1997 PSA#1945

National Cancer Institute, Research Contracts Branch, TCS, 6120 Executive Blvd, Room 603, MSC 7220, Bethesda Md 20892-7220

A -- IN VITRO SCREENING AND EVALUATION OF CHEMICALS AND PRE-CLINICAL DRUGS FOR IN VIVO TOXICOLOGY SELECTION SOL RFP NCI-CB-87016-58 DUE 121797 POC Michael Veesart, Contract Specialist, (301) 496-8620 WEB: Research Contracts Branch homepage, http://rcb.nci.nih.gov/. E-MAIL: Michael Veesart, Contract Specialist, MV64b@nih.gov. The Office of the Director, Division of Cancer Biology, National Cancer Institute has a need for contracts to support the project entitled "In Vitro Screening and Evaluation of Chemicals and Preclinical Drugs for In Vivo Toxicology Selection." Proposals are now being solicited for contracts to perform Task I, work associated with the Mouse Lymphoma Assay and Task II, work associated with the Salmonella Typhimurium Assay. Under Task I, offerors must document their ability to induce mutations in the Mouse Lymphoma Assay. Of approximately 25 -- 30 samples per year, up to five will not be coded samples of chemical compounds but will be human urine specimens. A number of compounds tested have unusual and hazardous properties including extreme acute toxicity, high reactivity, explosive or pyrophoric potential, or high volatilty. Both the safe handling of compounds and the generation of accurate and defensible data are critical. Under Task II, offerors must document their ability to induce mutations in Salmonella Typhimurium Assay. Of approximately 25 -- 30 samples per year, five will not be coded samples of chemical compounds but will be human urine specimens. One of the major questions to be investigated concerns the study of the dose dependancy effects of high levels of mutagens in the test system and whether high concentrations of liver enzyme S-9 preparation gives dose dependent formation of unusual metabolites of known mutagens and carcinogens. It is anticipated that RFP NCI-CB-87016 will be available on or about October 30, 1997. The RFP will be available on hardcopy or on the internet at http://rcb.nci.nih.gov/rfp.htm. The National Cancer Institute shall consider proposals from all responsible companies qualifying under Standard Industrial Code #8731. However, offerors must meet three mandatory requirements. To be considered, offerors must possess a facility in full compliance with Good Laboratory Practice for Nonclinical Laboratory Studies found in CFR Title 21, Part 58; must have examples of Salmonella and/or Lymphoma studies carried out under Good Laboratory Practices which have been or are capable of being submitted in support of a regulatory application to FDA or EPA and the proposed Principal Investigator must have documented experience in utilizing these specific microbial and/or mammalian cell mutagenicity assays on human urine specimens. All mandatory criteria must be met at the time of Best and Final Offer submission. Offerors may propose to carry out Task I or Task II or both Tasks together. It is anticipated that two cost-reimbursement completion type contracts will be awarded for a four-year period of performance with incremental funding each year. Offerors will be invited to submit proposal for Task I -- 11,476 direct labor hours and Task II -- 2916 direct labor hours. This is a recompetition of contract N01-CB-40509 currently performed by Microbiological Associates, Inc. No collect calls be accepted. (0275)

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