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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 27, 2014 FBO #4506
SOLICITATION NOTICE

65 -- Manufacture and Vialing of rRT-PCR Diagnostic Oligonucleotide Primers and Probes

Notice Date

3/25/2014
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

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

00HCVGDB-2014-69886
 

Archive Date

4/3/2014
 

Point of Contact

Linda M Young, Phone: (770) 488-2655
 

E-Mail Address

lml3@cdc.gov
(lml3@cdc.gov)
 

Small Business Set-Aside

N/A
 

Description

The Centers for Disease Control and Prevention intends to award a sole source firm fixed price purchase order to Integrated DNA Technologies, Inc., 1710 Commercial Park, Coralville, IA 52241-2760, for diagnostic oligonucleotide production and dispensing/labeling of rRT-PCR diagnostic oligonucleotide primers and probes. The oligonucleotide panel will be formulated in ICT’s Clinical and Commercial Manufacturing (CCM) suite, which is compliant with cGMP/ under the FDA’s QSR 21 CFR Part 820 requirements as it applies to oligo manufacturing, and certified to ISO13485-2003. CCM service level includes manufacturing to customer-designated oligo specifications with change approval rights in the IDT Clinical and Commercial Manufacturing suite. This includes Synthesis/purification of sequences via established processes; custom ESI Trace containing identification of expected sequences due to degenerate bases; synthesis log documentation; custom electronic batch record containing production history, user identification, equipment, and critical reagent lot numbers; aliquots shipped in sterile, 0.5mL micro packaging vials with 11 mm sterile closures; custom labels with format from previous work done for CDC on contract 200-2012-53735; and shipping charge with three dry ice shipments of bulk QC aliquots; post-fill QC aliquots; and final tube delivery. Dispensing/labeling of CDC-provided bulk material includes vialing primers (20.0 nmol final quantity and/or probes (5.0 nmol final quantity); sequences dispensed in sterile 0.5mL micro packaging vials with sterile 11mm caps; custom labels with format from previous CDC contract 200-2012-53735, and shipping to include two dry ice shipments of bulk QC aliquots and final tube delivery. All individual oligos produced by IDT will be analyzed by ESI mass spectrometry. Pass/fail criterion for oligos up to 39K Da is plus or minus 0.02% (plus or minus 2.8Da for all olgios with a calculated molecular weight of less than 14,000Da). Pass/fail criterion for oligos greater than 39K Da is plus or minus 0.04%. Minimum purity guarantee will be assessed by the method as listed above. Product quantification by optical density is performed on validated equipment and processes. Upon completion products will be shipped dry; oligos will be normalized to the nanomole amounts listed above and will be shipped in sterile tubes with custom labels. This contract action is for services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) and 10 U.S.C. 2304(c)(1). Interested persons may identify their interest and capability to respond to the requirement. This notice of intent is not a request for competitive quotations; however, all responses received within five (5) days of the issuance of this notice will be considered by the government. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any response should be emailed to the purchasing agent at lml3@cdc.gov by 4:30 p.m. EDT, April 2, 2014.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/00HCVGDB-2014-69886/listing.html)
 

Place of Performance

Address: 1600 Clifton Road, Atlanta, Georgia, 30333, United States

Zip Code: 30333
 

Record

SN03319188-W 20140327/140325234330-c4deac5f5a90ee8846be781b4b868ebb (fbodaily.com)
 

Source

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

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