Liquid nitrogen dewars for the VA SAN diego pathology and laboratory services department.

This Amendment is to correct the line items and outline the delivery schedule for Solicitation # 36C26219Q0376.
The correct line items and quantities are listed below:
Delivery of dewars occurs every Thursday during business hours of 0800 to 1530.
No other terms or conditions are changed by this Amendment..

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..