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FBO DAILY ISSUE OF JUNE 09, 2012 FBO #3850
SOLICITATION NOTICE

B -- GMP Genectic Sequencing

Notice Date
6/7/2012
 
Notice Type
Presolicitation
 
NAICS
541690 — Other Scientific and Technical Consulting Services
 
Contracting Office
Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
 
ZIP Code
30341-4146
 
Solicitation Number
2012-45121
 
Point of Contact
Cherie J. Katin,
 
E-Mail Address
chk5@cdc.gov
(chk5@cdc.gov)
 
Small Business Set-Aside
Total Small Business
 
Description
2012 - 45121 Project Purpose -The purpose of this acquisition is to obtain DNA sequencing services performed by a facility that conducts projects compliant with FDA Good Laboratory Practices regulations (21 CFR 58). The service will involve genotyping the hemagglutinin (HA) gene of influenza B viruses from samples containing viral ribonucleic acid (RNA) isolated from clinical specimens. These data are used by the Government to assess performance of a CDC real-time RT-PCR diagnostic test and may be used in 510(k) premarket applications to the FDA. Scope of Work -Influenza B virus RNA will be isolated from 100-300 clinical specimens by the CDC or one of its collaborators during a clinical evaluation of the CDC real-time RT-PCR diagnostic test. A sample of the purified influenza B virus RNA from each specimen will be transferred to the contractor. The sequencing contractor will conduct the project under the requirements of Good Laboratory Practices (GLP) (21 CFR 58). The contractor will deliver sequencing data, alignments, and a final audited report to the CDC. All study documentation and records will be retained by the contractor according to FDA requirements. this is a Total Small Business set aside
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2012-45121/listing.html)
 
Record
SN02769965-W 20120609/120608000500-e82189c60641725e6b5f3e65713dfe04 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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