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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 09, 2019 FBO #6287
SOLICITATION NOTICE

68 -- This Solicitation is for a base plus 4 option year contract to deliver Liquid Nitrogen, in 180-liter dewars at 22 psi, directly to the Pathology & Laboratory Services Dept. at the VA San Diego Healthcare System.

Notice Date
2/7/2019
 
Notice Type
Combine Synopsis/Solicitation
 
NAICS
325120 — Industrial Gas Manufacturing
 
Contracting Office
Department of Veterans Affairs;Network Contracting Office 22;4811 Airport Plaza Drive;Suite 600;Long Beach CA 90815
 
ZIP Code
90815
 
Solicitation Number
36C26219Q0376
 
Response Due
2/14/2019
 
Archive Date
3/16/2019
 
Point of Contact
bryan.boggs2@va.gov
 
Small Business Set-Aside
Service-Disabled Veteran-Owned Small Business
 
Description
This Solicitation is for a Base plus 4-Option Year Contract for the delivery of Liquid Nitrogen in 180-liter dewars at 22 psi directly to the Pathology & Laboratory Services Department at the VA San Diego Healthcare System. In accordance with 38 USC 8127(d) Veterans First Contracting Program, and VAAR 852.219-10 VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside, only offers from contractors listed on the VETBIZ website as an SDVOSB contractor will be considered. All contractors are advised to review the reclassification of dewars of Liquid Nitrogen by the FDA. Under the current FDA requirements, the product is required to be considered a drug. As a drug it must be strictly labelled and named as a drug. Therefore, all refills of open-mouth dewars are no longer possible on site because the FDA is now requiring each container of Liquid Nitrogen to have a specific lot number attached when it is filled at the branch level. If a container is on site, it is not possible for the container to have a unique lot number unless the contractor picks up the dewars, fills them on their premises, and return the full dewar to the end user. The changes being enforced are outlined in 21 CFR Part 820. Firms filling large cryogenic containers with Nitrogen, NF that are used to fill small dewars are not required to register as device establishments, list their devices and comply with the Quality System regulation (21 CFR Part 820), if they are registered as a drug manufacturer and the large cryogenic container is labeled and manufactured/filled according to relevant drug regulations; and firms filling small dewars from large cryogenic containers are not required to register as device establishments, list their devices and comply with the Quality System regulation (21 CFR Part 820), if they utilize and document the use of the large cryogenic containers. The large containers must be filled and labeled according to relevant drug regulations. All questions must be emailed to bryan.boggs2@va.gov by 1200 noon PST on Tuesday, 2/12/2019, to allow time to post a response on FBO. All offers must be emailed to bryan.boggs2@va.gov by 1200 noon PST on Thursday, 2/14/2019. No late or incomplete offers will be considered. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (07-FEB-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
 
Web Link
Link To Document
(https://www.fbo.gov/spg/VA/LBVANBC/VAMD/36C26219Q0376/listing.html)
 
Place of Performance
Address: VA San Diego Healthcare System;3350 La Jolla Village Drive;San Diego, CA
Zip Code: 92161
Country: USA
 
Record
SN05215920-F 20190209/190207230047 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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