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COMMERCE BUSINESS DAILY ISSUE OF APRIL 22,1999 PSA#2330DHHS/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) Loren Data Corp. http://www.ld.com (SYN# 0012 19990422\B-0007.SOL)
B - Special Studies and Analyses - Not R&D Index Page
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