SOLICITATION NOTICE
66 -- VSDB Life Technologies Reagents and Supplies - Supply List
- Notice Date
- 4/13/2017
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument 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
- 2017-09035
- Archive Date
- 5/12/2017
- Point of Contact
- Maria S Shamburger,
- E-Mail Address
-
HEG9@cdc.gov
(HEG9@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- List of items to be purchased The Centers for Disease Control and Prevention, NCIRD/ID/VSDB, 1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a sole source contract in accordance with FAR 6.302-1 to Life Technologies, 5791 Van Allen Way Carlsbad, CA 92008-7321, for the procurement of supplies and reagents from Life Technologies that are produced only by Life Technologies and/or meet approved technical requirements mandated by the Virology, Surveillance, and Diagnosis Branch (VSDB) Quality Management Systems, FDA 510(k) clearance of diagnostic assays, and Clinical Laboratory Improvement Amendments (CLIA) standards. The statutory authority permitting other than full and open competition is 41 U.S.C. 253(c)(1) as cited in FAR 6.302-1, "Only one responsible source and no other supplies or services will satisfy agency requirements." VSDB uses specific instrumentation designed and produced solely by Life Technologies for which parts, reagents and consumables are only provided by that vendor. These supplies and reagents have been qualified to meet technical laboratory standards and incorporated into standard operating procedures throughout the Branch. The VSDB requires reagents and supplies solely from Life Technologies because either 1) Life Technologies is the sole manufacturer and distributor or 2) reagents available solely through Life Technologies are used in diagnostic platforms previously cleared by FDA, certified by CLIA, and/or used to record "Good Laboratory Practices" (GLP) conditions required for development of vaccine seed viruses (viruses that will be used by manufacturers to produce influenza vaccine). FDA clearance of diagnostic assays using Life Technology specific-reagents is a process resulting in approval by FDA to allow use of VSDB-developed laboratory tests in hundreds of domestic and international public health laboratories, clinics and hospitals. Once these assays are cleared by FDA, they cannot be modified (including the specific reagents used) without re-application and approval, which is a time-consuming process affecting all laboratories that uses these critical diagnostic tests. Because modification of testing protocols, including any reagents used, would require re-certification/approval by FDA, this would be a detriment not only to the CDC's influenza virus testing capabilities, but also to domestic and international public health laboratories that depend (often solely) on the diagnostic assays developed and provided by VSDB. Life Technologies reagents/supplies are used solely in the influenza diagnostic FDA clearance process because they have been tested, optimized and validated for many years and shown to have superior testing outcomes for the detection of influenza viruses in clinical specimens. CLIA performance standards and certification also require only Life Technology reagents/supplies because they have proven to be the only reagents/supplies that produce accurate, reproducible laboratory test results (i.e., antiviral resistance screening of seasonal influenza viruses), which are now written into CLIA certified laboratory standard operating procedures. GLP vaccine development performed by VSDB also uses only Life Technologies supplies/reagents for the purposes of developing vaccine seed viruses that meet US government safety and performance standards. Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement, proposal or quotation which shall be considered by the agency. Please forward the capability statement and/or pricing information to Maria Shamburger, Contracting Officer, Reference 2017-09035, Centers for Disease Control, Procurement and Grants Office, ATTN: Maria Shamburger, MS: K14, 2920 Brandywine Road, Atlanta, GA 30341. All vendors must be registered in the System for Award Management (SAM) prior to an award of a federal contract. The website is: www.sam.gov. The Government will review any/all capabilities statements and pricing information submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement. If no affirmative responses are received within 15 days, negotiations will be conducted with the Life Technologies as the only source and a contract will be issued without any additional notices being posted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2017-09035/listing.html)
- Record
- SN04472165-W 20170415/170413235407-68441846cbc0acc5a29c37bc6fbcd57c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |