DHHS/PHS/FDA/Office of Facilities, Acquisitions, And Central Services, Division Of Contracts and Program Management, HFA-511(ITCB), 5600 Fishers Lane, Rockville, MD 20857

D -- DRUG USE DATABASES SOL 223-00-5500 DUE 042800 POC Julie Pearson, Contract Specialist -- Phone 301-827-7155, Fax 301-827-7151. E-MAIL: Julie Pearson -- Contract Specialist, jpearso1@oc.fda.gov. The Food and Drug Administration and the Center for Drug Evaluation and Research intends to issue a solicitation for multiple contracts to access a variety of databases that will assist with our mission to describe prescription drug utilization at a national level in the U.S. The intent is to award contracts to one or more organizations with databases that meet our data needs for prescription drug use information in the following two areas:  drug use in the inpatient setting (which may include hospitals or long-term care facilities);  ambulatory or outpatient longitudinal drug use on a patient-specific level With regard to inpatient drug use, all drugs used on a product- and substance-specific level by a patient during a hospital stay are required. All discharge diagnoses and procedures associated with the hospitalization, as well as patient demographics, should also be available. Additionally, the Agency is interested in accessing patient-level data that describes prescription drug use in individuals over time, i.e., longitudinally. These longitudinal data must be in an ambulatory or outpatient setting and must follow uniquely identifiable individuals over time for description of drug utilization and, if possible, medical diagnoses. Description of use of concomitant therapies is also of interest in both settings. For each type of drug utilization data (inpatient and longitudinal), FDA requires the ability to use these databases to estimate drug utilization patterns in the total U.S. population (if relevant) or to a national sub-population of interest. This may involve the use of projection methodology, which must be valid, reliable and robust (with regard to drug utilization specifically) and the methods fully disclosed. If such methodology has not been developed, a commitment to collaborate with FDA investigators to develop it within a reasonable timeframe is necessary. Demographic information of all patients and/or institutions included in the sample used for projection should also be available. Access to the data should be unlimited, direct, desktop and in real-time. The access should be via Internet, Telnet, through a local area network or some other multi-user alternative. If access is through an interface, it must be user-friendly and transparent. Onsite demonstration of the database will be required, as well as training, documentation and a level of ongoing technical support. Full disclosure of database construction, coding and configuration is required to allow Agency staff to appropriately interpret findings and projections. For regulatory requirements, FDA will need the ability to download and archive data. No personal patient identifiers would be required and appropriate clearance mechanisms would be established pertaining to FDA's use of the data in a public forum. All responsible sources may submit a bid, proposal, or quotation which shall be considered. Interested offerors may request a copy of the solicitation by sending a written request by mail or fax to: Mail: Food and Drug Administration Attn: Julie Pearson (HFA-511, Room 2121) 5630 Fishers Lane Rockville, MD 20857 Fax: 301-827-7155 In addition, the FDA is also conducting a market survey. Interested offerors should provide catalogs, brochures or any descriptive literature about the services, systems or products that they currently have available that would satisfy the above requirement to the above address by May 5, 2000. Please indicate if you are a large or small business as well. Posted 04/10/00 (W-SN443270). (0101)

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