D -- PEDIATRIC INPATIENT DRUG UTILIZATION DATABASE

Notice Date

September 13, 2000

Contracting Office

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

ZIP Code

20857

Solicitation Number

223-00-5502

Response Due

November 3, 2000

Point of Contact

Contract Specialist -- Leonard Grant (301)827-7154 or Contracting Officer -- Dennis Hunt (301)827-7152; Fax for both (301)827-7151

E-Mail Address

Leonard Grant, Contract Specialist, FDA (lgrant@oc.fda.gov)

Description

The Food and Drug Administration (FDA) intends to issue a solicitation for the development of a pediatric inpatient drug utilization database. 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. The database will include a minimum of data from 12-24 pediatric centers in the first year and significant expansion will be required so that a minimum of data from 56 pediatric centers will be included within the first five years. 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 and implement an acceptable 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. Access to the data will be unlimited, unrestricted, direct, desktop and in real-time. The access will be one of the following: Internet, Telnet, or Local Area Network. If access is through an interface, it must be user-friendly and transparent. Onsite training in access and use of the database will be required, as well as documentation and a level of ongoing technical support. Full disclosure of database construction, coding and configuration is required to allow FDA staff to appropriately interpret findings and projections. For regulatory requirements, FDA will need the ability to download and archive data. The FDA is not interested in identifying specific hospitals or patients. The FDA needs to understand the demographic characteristics of the participating health care institutions (e.g. census region, number of beds, bed size, geographic information, types of services, etc.) and their respective pediatric patients (e.g. age, gender, diagnosis and procedure profiles) to draw national conclusions regarding pediatric drug utilization. Further, the FDA needs to be knowledgeable about the database construction and configuration to insure that investigations and subsequent findings are scientifically sound. The FDA requires that the database be anonymized to insure hospital and patient confidentiality. Appropriate clearance mechanisms will be established pertaining to FDA's use of the data in a public forum. All responsible sources may submit a proposal for consideration. The solicitation for this requirement will be available on or about 10/2/00 on the FDA web site at http://www.fda.gov/oc/ofacs/contracts. Prospective offerors are responsible for downloading the solicitation and amendments. These documents will be in portable document format (pdf) and can be read and printed with Adobe Acrobat Reader Software version 3x or above. A link to the free downloadable Adobe Acrobat Reader software is available on the FDA web site. It is the offeror's responsibility to monitor the FDA web page for the release of the solicitation and amendments. Hard copies will be provided to recipients eligible under the Americans with Disabilities Act and the Rehabilitation Act upon request.

Record

Loren Data Corp. 20000915/DSOL006.HTM (W-257 SN496271)