DHHS/PHS/FDA/OCGM/Division of Contracts and Procurement Management/Contracts Operations Branch, HFA-512, 5600 Fishers Lane, Park Building, Room 3-32, Rockville, Maryland 20857

B -- EXPLORATION OF THE USE OF A THIRD-PARTY PAYER MEDICAL DATABASE: PILOT STUDY OF THE COMPLICATIONS OF CHRIONIC VILLUS SAMPLING (CVS) SOL 223-95-6005 DUE 061395 POC Susan Gane, Contracting Officer (301) 443-4420 The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) has a requirement to provide a computerized dataset from an HMO-Type medical facility that contains data for a pilot study of chorionic villus sampling (CVS). The major goal of the study with FDA is to conduct a preliminary evaluation of the suitability of comprehensive health care data sources for the epidemiologic study of medical devices. (0117)

Loren Data Corp. http://www.ld.com (SYN# 0017 19950428\B-0006.SOL)