Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF MAY 15,1997 PSA#1846

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 -- DRUG QUALITY REPORTING SYSTEM SOL 223-97-3008 DUE 063097 POC John D. Speer, Sr. Contract Specilialist, M.Debroah Smith-Castle, Contracting Officer, (301) 443-0424, FAX (301)443-3651 The Food and Drug Administration (FDA) has a requirement for a Drug Quality Reporting System (DQRS). The DQRS is a voluntary information collection system and is one of the post marketing surveillance programs which makes up the agency's MEDWATCH program. It is used by the FDA to support the surveillance of the quality of both prescription and non-prescription drug products in the market place. Through MEDWATCH, all categories of pharmacy practitioners and selected other health care professionals can quickly communicate their observations and/or concerns regarding drug product quality directly to FDA. the system will invovle but not be limited to: 1) developing a promotional plan to encourage reporting by pharmacists, pharmacy technicians, and other allied health professionals; 2) developing mailouts and other promotional literature from information provided by FDA; 3) directing promotion of the voluntary program to practicing pharmacists (e.g. periodic mailings, videotape media, presentations at pharmacy meetings, etc.; 4) serving as the focal point for receipt of drug quality medication error and drug shortage reports and 5) entering report information using FDA developed software, into the AgencyUS on-line computer data file. A three year period of performance is anticipated. Anticpated release date for the solicitation is on or about 30 May 1997. (0133)

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