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

R -- CONSUMER SAFETY OFFICER SOL 228431-00-98 DUE 081898 POC Trudy Dartouzos, Contract Specialist, ph: 301/827-7165; fax: 301/827-7103 See Note #1. The Food and Drug Administration [FDA], Center for Biologics and Evaluation [CBER] intends to award a purchase order for professional services for a Consumer Safety Technician. The Statement of Work is as follows: Cell and gene therapy: Working with product and clinical review staff in processing submissions related to molecular biology, virology, and oncology that focus on cellular therapy and those utilizing reengineered genetic material. In addition, the following duties will be performed: 1] independently preparing non-standard correspondence to industry and consumers; 2] attending meetings between agency reviewers and related industry and prepares minutes of those meetings; 3] tracking the status of reviews in progress; notifies team of action dates; prepares adhoc reports; 4] maintaining information files on products regulated by office; 5] organizing completed actions for filing in the central Document Control Center [DCC], and 6] serving as liaison with DCC and resolve problems in document processing. The expertise for this position should be biological or chemical sciences, although medical sciences are acceptable. Written quotes due by COB 2:00 pm 8/18/98. Posted 07/30/98 (W-SN230595). (0211)

Loren Data Corp. http://www.ld.com (SYN# 0112 19980803\R-0026.SOL)