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

D -- PEDIATRIC INPATIENT DRUG UTILIZATION DATABASE SOL 223-00-5502 DUE 081800 POC Contract Specialist -- Leonard Grant (301)827-7154 or Contracting Officer -- Dennis Hunt (301)827-7152; Fax for both (301)827-7151 E-MAIL: Leonard Grant, Contract Specialist, lgrant@oc.fda.gov. The Food and Drug Administration (FDA) intends to negotiate an Indefinite Delivery Indefinite Quantity (IDIQ) Contract with the National Association of Children's Hospitals and Related Institutions (NACHRI) for the development of a pediatric inpatient drug utilization database over a five (5) year period. The FDA's Center for Drug Evaluation and Research (CDER) Pediatric Implementation Team (PedIT) has a need for the creation of a validated, nationally representative database describing pediatric inpatient drug use. This database shall include multiple pediatric inpatient care arenas such as freestanding hospitals, inpatient pediatric units, pediatric hospital centers, teaching and community institutions, long-term care, rehabilitation centers, mental health clinics, and other pediatric specialty wards and institutions. Although the database may initially include a minimum of data from only 12-24 pediatric centers in the first year, significant expansion will be required so that a minimum of data from 56 pediatric centers will be included within the first five years. NACHRI has over 160 pediatric hospitals and units that specialize in many areas of pediatric medicine. One of their main activities is to collect data from member hospitals and aggregate the information to produce profiling and benchmarking reports to assist in hospital management. In this capacity, NACHRI collects or has access to detailed clinical and drug-related pediatric inpatient information. Due to the national scope of CDER's mission, an essential part of this project will be the ability to estimate pediatric drug utilization patterns in the total U.S. population using this database. This will involve the use of projection methodology, which must be valid, reliable and robust (with regard to drug utilization in the pediatric population specifically) and the methods fully disclosed. A commitment to collaborate with FDA investigators to develop this methodology within six months of the contract award date is necessary. As a part of the projection development process, information on institutions included in the sample used for projection must be available. Other than full and open competition is justified because only NACHRI has the unique ability to gather the detailed data the FDA requires from a wide enough range of pediatric care centers, and integrate it into a medium that will be directly accessible online to the FDA community. See Note 22. Posted 06/23/00 (W-SN467924). (0175)

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