DHHS/PHS/FDA/Office of Facilities, Acquisitions, And Central Services, Division Of Contracts and Program Management, HFA-511(ITCB), 5600 Fishers Lane, Rockville, MD 20857

B -- PROFESSIONAL SERVICES FOR BOARD CERTIFIED TOXICOLOGISTS TO REVIEW & EVALUATE REPORTS SOL 008219 DUE 072700 POC Trudy Dartouzos, ph: 301/827-7165; fax: 301/827-7103 See note #1. The Food and Drug Administration [FDA], Center for Veterinary Medicine [CVM], intends to award a purchase order using the simplified acquisition process for the following Scope of Work: Provide board certified toxicologist to review and evaluate final study reports and raw data from Good Laboratory Practices [GLP] safety studies submitted by pharmaceutical companies to support the approval of new animal drugs for use in dogs and cats. Provide written, comprehensive evaluation of the studies and conclusions drawn from the data submitted by drug sponsors. Evaluate final study reports along with raw data to determine if conclusions drawn by the drug sponsor are supported by the raw data. Evaluate clinical observations, chemistries & hematology reports, necropsy findings, and histopathology results. Written reports should include determinations of adequacy of conduct of the study, validity of tests, interpretation of results for determining safety of new animal drug. Prepare written reportdescribing study design, methods, materials, results and conclusions, adequate detail to characterize toxicity of the drug, basis for an adequate margin of safety that should exist for approval of new animal drug, state conclusions of toxicologist, also included is review of safety section of the Freedom of Information Summary [FOI] prepared by pharmaceutical sponsor. Written report is required in hard copy and electronic disk or e-mail copy in microsoft word format. Hourly rates required. Period of performance: one year. Clauses pertaining to confidentiality, conflict of interest, personnel security, copyright, & 52.232.33 Mandatory Information of Electronic Funds Transfer Payment apply. This procurement will be awarded as a simplifed acquisition in accordance with FAR Subpart 13.5. Written quotes can be faxed to Trudy Dartouzos at 301/827-7103 due by 2 pm 7/27/00. Posted 07/13/00 (W-SN474543). (0195)

Loren Data Corp. http://www.ld.com (SYN# 0022 20000717\B-0010.SOL)

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