SOLICITATION NOTICE
D -- Data Mining of Center for Devices and Radiological Health CDRH Adverse Events
- Notice Date
- 9/1/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541511
— Custom Computer Programming Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 12693404
- Response Due
- 9/15/2004
- Archive Date
- 9/30/2004
- Point of Contact
- Mary Farrell, Contract Specialist, Phone 301-827-9765, - Phillip Osborne, Contracting Officer , Phone 301-827-2476, Fax 301-827-7101,
- E-Mail Address
-
mary.farrell@oc.fda.gov, phillip.osborne@fda.gov
- Description
- The Food and Drug Administration (FDA) intends to award a sole source purchase order to Lincoln Technologies, Inc. of Wellesley, Hills, MA 02481. Lincoln Technologies has participated in a multi-year collaboration with the FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that has resulted in Lincoln?s creation of WebDVDME. Lincoln will collaborate further with the FDA to test and deploy WebDVDME as a tool for assisting safety evaluators and epidemiologists in both CDER and CBER. Data mining is a technique for extracting meaningful, organized information from large complex databases. There has been increasing interest in the use of data mining technology to enhance the FDA?s ability to monitor the safety products after they have been approved for use. The Center for Devices and Radiological Health (CDRH) received approximately 100,000 adverse event reports annually. Currently, no standard statistical tools are in place to detect signals among these reports. The purpose of this project is to support an evaluation by CDRH of the potential value of data mining in the device setting. This tool may optimize evaluation resources and enhance CDRH?s ability to identify device-related safety concerns. The use of enhanced data mining techniques may improve upon CDRH?s current ability to identify adverse event patterns in post-market safety databases. An award will be made ten (10) days from the date of this notice. Sources with the capability of performing these services must submit descriptive literature which fully demonstrates their capabilities. The FDA will review and consider these submissions in making its award decision. The award will be made as a simplified acquisition in accordance with FAR 13.5. Email inquiries should be sent to Mary.Farrell@FDA.GOV.
- Record
- SN00662965-W 20040903/040901211806 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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