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FBO DAILY ISSUE OF SEPTEMBER 15, 2005 FBO #1389
SOLICITATION NOTICE

B -- Leishmania Validation Studies

Notice Date

9/13/2005
 

Notice Type

Solicitation Notice
 

NAICS

541710 — Research and Development in the Physical, Engineering, and Life Sciences
 

Contracting Office

US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
 

ZIP Code

21702-5014
 

Solicitation Number

W81XWH-05-P-0044-P00002
 

Response Due

9/28/2005
 

Archive Date

11/27/2005
 

Small Business Set-Aside

N/A
 

Description

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to award a modification on a sole-source basis to Cepheid, Sunnyvale, CA, pursuant to FAR 6.302-1, for the completion of leishmania validation studies. A modification is planned to fund a third lot of leishmania PCR leishmania major beads which is necessary to obtain stability data prior to submission of the 510(K) to FDA in FY06. The PCR beads will also be used in support of clinical validation studies supporting the 510 (K) application. A third validation study is needed and is expected to substantiate the customers (the Walter Reed Army Institute of Research) position they intend to submit to the FDA. To switch to another vendor at this point in the studies would inva lidate the studies completed to date and result in the duplication of costs to the Government that is not expected to be recovered through competition. Cepheid has licensed the intellectual property (IP) necessary to use the leishmania PCR chemistries to be produced and have agreed to take over the responsibilities of the FDA cleared 510(K) application. Laboratory validation studies to support an application to the FDA have already begun using PCR chemistries produced by Cepheid. To switch to a new manuf acturer at this point would require all of these validation studies to be repeated. This would result in mission failure for this project and delay in getting an urgently needed diagnostic assay to the military medical community. USAMRAA intends to award this modification under Simplified Acquisition Procedures. A firm-fixed-price-type modification is planned. The period of performance will be one month from time of award. Interested respondents who feel that they are capable of meeting these requireme nts may identify their interest by submitting technical documentation and resumes demonstrating capability to Dana Herndon at FAX No. 301-619-3002 by 3:00 p.m. E.S.T., Thursday, 28 September 2005. This notice of intent is not a request for competitive pro posals. No telephone requests will be accepted.
 

Place of Performance

Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD

Zip Code: 21702-5014

Country: US
 

Record

SN00894086-W 20050915/050913212601 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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