B -- HUMAN IONIC CURRENT (HERG)=20

Notice Date

September 17, 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

Reference-Number-096023

Response Due

September 26, 2001

Point of Contact

Ida Cofield, Contract Specialist, Phone (301) 827-7156, Fax (301) 827-7151, Email icofield@oc.fda.gov

Description

The Food and Drug Administration intends to issue a Purchase Order on a sole source basis to Georgetown University to perform studies to evaluate the ability of in virto preclinical assays to predict the potential of a drug to prolong the QT interval and induce torsade de pointes in humans. Fifteen presently or recently marketed drugs will be studied for inhibitory effects on the ionic channel encoded by HERG, when stably expressed in a mammalian cell line. The potency of these drugs on HERG current will be determined. In certain cases, e.g., where HERG data is available, electrophysiological studies will be substituted, including evaluation of a drug's effects on action potential duration in isolated ventricular myocytes. Drugs to be evaluated will include those believed to induce torsade de pointes under conditions of clinical use, and those believed to not induce torsade de pointes under conditions of clinical use. FDA will provide the list of drugs. The laboratory will provide the drug substances to be tested. Simplified Acquisition procedures will be used in accordance with FAR Part 13. The Standard Industrial Classified (SIC) Code for this acquisition is 8733 and the North American Industry Classification System (NAICS) Code is 541710. All responsible sources that can provide and meet the above requirement shall submit a response by mail or fax. Evaluation/Award will be based on the offer that provides the best value to the government. The Purchase Order is being issued on a sole source basis because by collaborating with Georgetown, FDA will be able to tie into an ongoing research effort by that laboratory to evaluate pre-clinical methodologies predictive of drug ?induced torsade de pointes.

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/FDA/DCPM/Reference-Number-096023/listing .html)

Record

Loren Data Corp. 20010919/BSOL002.HTM (D-260 SN50X8A9)