Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF APRIL 22,1999 PSA#2330

DHHS/PHS/FDA/Office Of Facilities, Acquisition, And Central Services, Division of Contracts and Program Management, HFA-512(COB), 5600 Fishers Lane, Rockville, MD 20857

B -- ACTIVE POSTMARKETING SURVEILLANCE METHODS: HOSPITAL PILOT SOL 223-99-6101 DUE 060899 POC Contact Susan Pearlman, 301/827-7167 Contracting Officer, Paul Scarborough, 301-827-7168 The Center for Devices and Radiological Health (CDRH), The Food and Drug Administration (FDA), has a requirement to develop an active gender-based surveillance method, that exploits advancing computerization of medical logs and records, for discovering signals of adverse events due to medical devices and drugs. This requirement shall utilize experienced researchers to devise a more comprehensive system of actively searching for adverse event signals in a hospital setting. Feasible algorithms for detecting signals of device or drug adverse events will be tried in a hospital that has a large proportion of women patients (obstetric or geriatric). The assessment of the system shall include analysis of which types of signals are borne out and whether gender plays a role in either analysis. The solicitation will only be available on the FDA web page at http://www.fda/gov/oc/ofacs/contracts/. Prospective offers are responsible for downloading the solicitaiton and amendments. These documents will be in a portable document format (pdf). A link to the free downloadable Adobe Acrobat Reader software will be available at the same site. It is the offeror' s responsibility to monitor the FDA web page for the release of the solicitation and amendments. Posted 04/20/99 (W-SN322265). (0110)

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