DHHS/PHS/FDA/Office of Facilities, Acquisition and Central Services, Contracts Operations Branch, HFA-512, 5600 Fishers Lane, Park Building, Room 3-32, Rockville, MD 20857

B -- AUTOMATED MEDICAL RECORDS SOL 223-96-6053 DUE 041096 POC Susan Pearlman, Contract Specialist, (301) 443-4420, M. Deborah Smith-Castle, Contracting Officer, (301) 443-3651, FAX (301) 443-3651 The Center for Devices and Radiological Health (CDRH), The Food and Drug Administration (FDA), has a requirement to explore the feasibility of performing postmarket studies for devices using large automated data-bases with searchable electronic patient records. This contract is to develop a new mechanism for postmarketing surveillance for devices. This would involve using existing electronic data sets to perform timely and cost-effective ad hoc studies that could address urgent postmarketing regulatory questions. Even though most device use is not captured in automated billing records, it may be accessible by automated data searches of data-bases for which patient medical records are maintained in electronic rather than paper form. A three year period of performance is anticipated for this requirement. (0054)

Loren Data Corp. http://www.ld.com (SYN# 0019 19960226\B-0003.SOL)