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

A -- PRECLINICAL TOXICOLOGY OF CHEMOPREVENTIVE AGENTS SOL N01-CN-75033-05 DUE 092197 POC Gary P. Topper, Contracting Officer, 301-435-3798 WEB: Research Contracts Branch RFP Page, http://wwwrcb.nci.nih.gov/rfp.htm. E-MAIL: Gary P. Topper, topperg@rcb.nci.nih.gov. ELECTRONIC RFP ANNOUNCEMENT. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. The chemoprevention drug development program from the Division of Cancer Prevention and Control, National Cancer Institute, has the mission of identifying safe and effective chemical agents for preventing human cancer. A primary function of the chemoprevention program is the identification and evaluation of agents for possible utilization in clinical trials in humans. Candidate agents, from natural resources or synthesized, have been evaluated for anti-cancer efficacy in various screening tests. However, before a decision can be made as to their suitability for Phase I clinical trials in humans, the agents must be evaluated for toxicity in animals. The basic objectives of this project will be to evaluate the acute, subacute/subchronic, and chronic toxicity of designated agents. A summary of the task areas for this project are as follows: TASK I, Mutagenicity Testing; TASK II, General Toxicology in Rodents and Dogs; TASK III, Reproductive Toxicity Studies in Rodents and Rabbits; and TASK IV, Specialized Studies. The studies shall be conducted under the Food and Drug Administration Good Laboratory Practice Regulations as published in the Federal Register (Vol. 43, No. 247), Friday, December 22, 1978, pp. 59986-60025, or CFR Title 21, Part 58. The laboratory shall be AAALAC International accredited, NIH/OPRR & USDA registered, and demonstrate an active Institutional Animal Care and Use Committee. The animal facilities shall comply with NIH Guidelines and with Public Law 89-544, "The Laboratory Animal Welfare Act of August 24, 1966" as amended by Public Law 91-579 of December 24, 1970. The Master Agreement Announcement (MAA) is scheduled for electronic release on/about July 31, 1997 with proposals due on September 21, 1997. It is estimated that multiple Master Agreements will be awarded as a result of this announcement, each having a sixty month period of performance.The Master Agreement (MA) contract mechanism is a prequalification to enable qualified sources to compete for and perform future Master Agreement Orders (MAOs). The MA itself is unfunded. The obligation of funds shall be accomplished solely through the award of Master Agreement Orders (MAOs). It is estimated that approximately five (5) MAOs will be awarded per year. The RFP may be accessed through the Research Contracts Branch Home Page by using the following Internet address: http://wwwrcb.nci.nih.gov/rfp.htm It is the offerors 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. Point of contact: Gary P. Topper, Electronic mail address: topperg@rcb.nci.nih.gov Fax: (301) 402-8579. No collect calls will be accepted. (0197)

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