National Institutes of Health, Division of Research Contracts, OCM/OA/OD, 6100 Executive Blvd., MSC 7540, Room 6E01, Bethesda, Maryland 20892-7540

A -- INVESTIGATIONAL NEW DRUG TOXICOLOGY FOR DRUGS TO TREAT ALZHEIMER'S DISEASE AND OTHER AGING-RELATED DISEASES SOL NIH-AG-99-03 DUE 041599 POC Teresa A. Baughman, Contracting Officer, 301-496-4487 WEB: Click here to download a copy of the RFP., http://ocm.od.nih.gov/drc/rfp.htm. E-MAIL: Click here to contact the Contracting Officer via, tb14j@nih.gov. The National Institute on Aging (NIH), National Institutes of Health (NIH) has a requirement to evaluate acute and chronic toxicity in rodents and dogs which are proposed to have potential use in the treatement of Alzheimer's disease and other aging-related diseases. The data generated from these studies will be used as part of the filing of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). The work to be performed includes toxicity evaluations using fully audited Good Laboratory Practices(GLP) dose range finding studies, GLP 13 week subchronic oral toxicity studies in rats and/or beagle dogs, and other ancillary studies. The dose range finding studies shall consist of hematology, clinical chemistry, necropsy, and tissue collection. Microscopic examination of fixed tissue shall be performed as necessary. The fully audited GLP subchronic studies shall involve hematological and clinical chemistry parameters, urinalysis, and opthalmological examinations. The Contractor's laboratory facility MUST be in compliance with the FDA GLP Regulations, as published in the 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. A three year cost-reimbursement type contract, with two 1-year option periods is anticipated. This project is set aside 100% for small businesses. The Standard Industrial Classification (SIC) Code is 8731. THE SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. It will be availiable on the following website: http://ocm.od.nih.gov/drc/rfp.htm on or about March 1, 1999. 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. All responsible small business sources may submit a proposal which shall be considered. No collect calls will be accepted. SEE NUMBERED Notes 1 and 26. Posted 02/12/99 (W-SN297997). (0043)

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