A -- New Therapeutic Targets for the Treatment of Neurodegenerative Disease, Diabetes Mellitus, Congestive Heart Failure, Oncologic and Immunologic Disease - Preclinical Toxicology

The address for the Contracting Office responsible for this solicitation is: National Institutes of Health, Division of Research Acquisition, OLAO, 6100 Executive Blvd., Room 6E01, MSC 7540, Bethesda, Maryland 20892-7540. The National Institute on Aging has a requirement to evaluate toxicity in rodents and dogs which are proposed to have potential use in the treatment of Alzheimer?s disease and other aging-related diseases. The data generated from these services will be used as part of the filing of an Investigational New Drug (IND) submission to the Food and Drug Administration (FDA). Specifically, the Contractor shall be required to conduct toxicology and pharmacology studies in accordance with the complete protocol requirements including an account for data on the agent?s in vitro cytotoxicity, biochemistry and schedule dependence as well as in vitro activity, if available. The Contractor shall: 1) validate the analytical methodology to quantitate drug levels; 2) determine bioavailability of drug after administration; 3) determine acute toxicity and plasma drug levels; 4) assess subacute toxicity; and 5) assess cardiotoxicity; neurotoxicity, immunotoxicity, mutagensis and bone marrow toxicity as specified by the Project Officer. The Contractor?s laboratory facility MUST be in compliance with the FDA Good Laboratory Practice Regulations (GLP), as published in December 22, 1978 Federal Register Volume 43, No. 247, pp. 59986-60025. In addition, the Contractor?s facility MUST be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International. The Contractor MUST also provide an animal welfare assurance indicating compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. A two-year cost-plus-fixed-fee type contract, with three 1-year option periods is anticipated. The North American Industry Classification System code is 541710. All responsible sources may submit a proposal, which shall be considered. No collect calls will be accepted. THE SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. It will be available on the following website: http://ocm.od.nih.gov/drc/rfp.htm and will be available on or about February 12, 2002 and proposals will be due 45 calendar days thereafter. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THIS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED.