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

A -- PRECLINICAL TOXICOLGY OF CHEMOPREVENTIVE AGENTS SOL N01-CN-85084-24 POC Curtis R. Foust (301) 435-3798 or Gary P. Topper (301) 435-3793 WEB: Research Contracts Branch RFP Page, http://rcb.nci.nih.gov/rfp.htm. E-MAIL: Curtis R. Foust, foustc@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 (DCP), 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. It is estimated that multiple Master Agreements (MA) will be awarded as a result of this announcement. Any MA awarded as a result of this solicitation will be in effect from the effective date to March 31, 2003. This solicitation will be open for the duration of the existing MA pool (through March 31, 2003) with due dates for receipt of proposals Semi- Annually, April 7 and October 7 (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 MASTER AGREEMENT HOLDERS ALREADY IN THE EXISTING MASTER AGREEMENT POOL NEED NOT RESPOND TO THIS ANNOUNCEMENT. CURRENT MASTER AGREEMENT HOLDERS INCLUDE: IIT Research Institute, Chicago, IL; MPI Research, LLC, Mattawan, MI; Southern Research Institute, Birmingham, AL; Springborn Laboratories, Spencerville, OH; SRI International, Menlo Park, CA; University of Illinois at Chicago, Chicago, IL. The Master Agreement (MA) contract mechanism is a pre- qualification to enable qualified sources to compete for and perform future contracts. The MA itself is unfunded. The obligation of funds shall be accomplished solely through the award of contracts. It is estimated that approximately five (5) contracts will be awarded per year. THE RFP MAY BE ACCESSEDTHROUGH THE RESEARCH CONTRACTS BRANCH HOME PAGE BY USING THE FOLLOWING INTERNET ADDRESS: http://rcb.nci.nih.gov/rfp.htm POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Point of contact: Curtis R. Foust, Electronic mail address: foustc@rcb.nci.nih.gov Fax: (301) 402-8579. No collect calls will be accepted. Posted 07/14/98 (W-SN222890). (0195)

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