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 -- CODING, ENTRY, AND QUALITY CONTROL OF MANDATORY/VOLUNTARY ADVERSE EXPERIENCE INFORMATION RELATED TO THE PERFORMANCE OF MARKETED MEDICAL DEVICES INTO VARIOUS COMPUTER SYSTEMS SOL 223-00-6001 DUE 020800 POC Contract Specialist, Susan Pearlman 301-827-7167;Contracting Officer, Paul Scarborough 301-827-7168 E-MAIL: Susan Pearlman, Contract Specialist, spearlma@oc.fda.gov. The Food and Drug Administration (FDA), has a requirement to provide services in support of the operation and development of adverse experience information systems that are maintained by the Center for Devices and Radiological Health (CDRH), CDRH develops and implements national programs to protect the public health in the fields of medical devices and radiological health. These programs are intended to assure the safety, effectiveness, and proper labeling of medical devices. The intent of the Request for Proposal (RFP) is to obtain operational and developmental support for the information systems which enable the FDA to enforce its responsibilities to monitor the performance, safety, and effectiveness of marketed medical devices. A working knowledge of the clinical aspects of medical devices and the Medical Device Amendments is necessary for the prospective contractor to understand the nature and scope of this effort. 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 solicitation and amendments. The RFP will be available on or about January 6, 2000. These documents will be in 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. This is set-aside for an 8(a) competitive procurement. Numbered Note #6. Posted 12/10/99 (W-SN407569). (0344)

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