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FBO DAILY ISSUE OF JUNE 19, 2004 FBO #0936
SOLICITATION NOTICE

65 -- Rapid HIV Test Kits w/Laboratory Confirmation Services

Notice Date
6/17/2004
 
Notice Type
Solicitation Notice
 
NAICS
325413 — In-Vitro Diagnostic Substance Manufacturing
 
Contracting Office
Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Rockwall Contracting Office, 5515 Security Lane Rockwall II, Suite 640, Rockville, MD, 20857
 
ZIP Code
20857
 
Solicitation Number
277-04-0065
 
Response Due
6/25/2004
 
Archive Date
7/10/2004
 
Point of Contact
David Westall, Contract Specialist, Phone 301-443-1436, Fax 301-594-0535, - Michelle Ringo, Contracting Officer, Phone (301) 443-4983, Fax (301) 594-0535,
 
E-Mail Address
dwestall@samhsa.gov, mringo@samhsa.gov
 
Description
Notice of intent to issue a sole source firm fixed price contract to: OraSure Technologies, Inc. 150 Webster Street Bethlehem, PA. 18015-1389 The statutory authority for this procurement is 41 USC 253(c)(1) as implemented by FAR6-302.1. The purpose of this contract is to purchase the following commercial items and services: CLIN 001: 560,000 OraQuick, or equivalent, rapid HIV test kits. CLIN 002: 11,200 OraQuick, or equivalent, rapid HIV test control kits. CLIN 003: 56,000 OraSure, or equivalent, oral specimen collection devices with confirmation lab services. The above items shall meet the following technical specifications: 1. Each CLIN must be Food and Drug Administration (FDA) approved. 2. CLIN 001 must have a Clinical Laboratory Improvement Amendment (CLIA) waiver. 3. CLIN 001 must be capable of detecting the presence HIV antibodies in bodily fluids (blood, oral fluid, and/or urine). The test sensitivity* must be at a minimum 99.6% (95% confidence interval [CI]=98.5%--99.9%), and test specificity must be 100% (95% CI=99.7%--100%), or comparable to other Food and Drug Administration (FDA)-approved enzyme Test. The proposed procurement is for commercial items and services for which the Government intends to solicit and negotiate with one source under authority of FAR 6-302. Interested parties may identify their interest and capability to provide the required items and services or submit proposals to the cognizant contracting office. This synopsis is not a notification or request for competitive proposals. The Government reserves the right to enter into a competitive acquisition if it is determined that it would be in the best interest of the Government to do so. A determination by the Government to proceed with a single source procurement based on responses to this synopsis is solely within the discretion of the Government. Information received in response to this synopsis will be considered solely for the purpose of determining whether or not to proceed with a competitive acquisition. The Government anticipates releasing the RFP on or about 23 June, 2004 with a closing date of 9 July, 2004. Interested parties may submit their proposals or statements of capability to: Dave Westall, Contract Specialist. Responses will be received until June 25, 2004.
 
Place of Performance
Address: 5600 Fishers Lane, Rockwall II, Suite 640, Rockville, MD
Zip Code: 20857
Country: USA
 
Record
SN00605269-W 20040619/040617211829 (fbodaily.com)
 
Source
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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