D -- D -- PEDIATRIC INPATIENT DRUG DATA

Notice Date

June 21, 2001

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Division of Contracts and Procurement Management, Office of Facilities, Acquisitions, and Central Svcs 5600 Fishers Lane, HFA-511, Rockville, MD, 20857

ZIP Code

20857

Solicitation Number

223-01-5505

Response Due

July 5, 2001

Point of Contact

Lynniese Cosey, Contract Specialist, Phone (301) 827-7158, Fax (301) 827-7151, Email lcosey@oc.fda.gov

Description

The Food and Drug Administration (FDA) intends to negotiate a Time-and-Materials(T&M) Contract with Child Health Corporation of America (CHCA for the purchase of pediatric inpatient drug utilization data over a three (3) year period. The FDA's Center for Drug Evaluation and Research (CDER) Pediatric Implementation Team (PedIT) has a need for data describing pediatric inpatient drug use in children's hospitals. Data, in the form of a CD-ROM, shall be delivered to the FDA on a quarterly basis. The data shall consist of a rolling 2 years, i.e., the most recent 8 quarters of hospital data available. It shall include all diagnoses, procedures and drugs utilized during each hospitalization in each hospital during that 2-year period, as well as demographic information on the hospitalized patients. Basic information (total number of operating beds, geographic location, number of admissions per year, status as an academic/nonacademic facility) on the hospitals whose data are included in each quarter shall also be available. Onsite training in access and use of the data shall be required, as well as documentation, including data dictionaries, and a level of ongoing technical and scientific support. The FDA is not interested in identifying specific hospitals or patients from these data, and requires that the data be de-identified to insure hospital and patient confidentiality. The FDA expects CHCA to fully adhere to all applicable HIPAA privacy rules. Mutually agreed upon and appropriate clearance mechanisms will be established pertaining to FDA's use of the data in a public forum. Other than full and open competition is justified because only CHCA has an established data base with the detailed pediatric data required by the FDA. See Note 22.=20

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/FDA/DCPM/223-01-5505/listing.html)

Record

Loren Data Corp. 20010625/DSOL009.HTM (D-172 SN50P6E7)