DHHS/FDA/Office of Facilities, Acquisitions, and Central Services, Division of Contracts and Procurement Management, HFA-521, 5600 Fishers Lane, Park Bldg., Rm. 3-40, Rockville, MD 20857

B -- EVALUATION OF VACCINE ADVERSE EVENTS INCLUDING ENCEPHALITIES & ENCEPHALOPATHY SOL 226479 DUE 061298 POC Trudy Dartouzos, Contract Specialist, ph: 301/443-2597 till 6/5/98. On 6/6/98 phone is 301/827-7165, Fax till 6/5/98 301/443-2651. On 6/6/98 fax number is 301/827-7107. The Food and Drug Administration [FDA], intends to award a purchase order to John Hopkins University for a collection of clinical information of reports of severe neurologic disorders following immunization to the Vaccine Adverse Event Reporting System [VAERs]. Phase I: Develop Case Classification Criteria. A panel of three [3] neurologists, two [2] epidemiologists and one [1] statistician to develop minimum criteria for establishing case definitions for probable cases, unclassified due to insufficient information, or as non-cases of encephalitis, encephalopathy, and multiple sclerosis. Phase II: Retrospective Case Classification Criteria. After FDA approves Phase I, neurologists will evaluate ten [10] reports to the VAERS system coded for encephalitis, encephalitis, encephalopathy, and multiple sclerosis [total approx. 30 reports] and categorize according to diagnositc criteria from Phase I. Tabulate and assess by techniques and case definition. Phase III: Prospective Testing of Case Classification Criteria: Contractor will develop standardized follow-up data to be administered to VAERS for each of the neurologic conditions from Phase II. Data will be pilot tested on 30-40 reports of each of the neurologic conditions in the Phases. Neurologists will review reports and classify into categories to be tabulated and assessed through statistical techniques. On-going technical reports identified shall be submitted through Phases I, II and III with a final report at end of project. Written or faxed quotations are required by COB 06/12/98. Note: Written quotations can be sent to 5600 Fishers Lane, Rm 3-32, Park Bldg., Rockville, MD 20857 until 6/6/98. After 6/6/98, written quotes should be sent by Federal Express to 5630 Fishers Lane, Rm 2132, Rockville, MD 20857. Send Fax to phone: 301/443-3651 till 6/6/98; after 6/6/98 send Fax quote to 301/827-7107. See number note #1. (0148)

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