Requirement for 5-mL glass vials for the storage and distribution of CBER Reference Standards and Reagents
Closed Solicitation Posted
- Solicitation number
- 75F40125Q128395
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- PSC
- 6640 Laboratory Equipment And Supplies
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration's National Center for Toxicological Research is seeking to procure 60,032 5-mL glass vials for the storage and distribution of CBER Reference Standards and Reagents. These vials must meet specific technical requirements including being made of Fiolax clear glass, suitable for low-temperature storage and shipping, break-resistant Type 1 borosilicate glass, chemically inert, and compatible with steam sterilization. The vials will support the Division of Biological Standards and Quality Control's critical mission of manufacturing and distributing biological reference standards, particularly for influenza vaccines. The government will evaluate offers based on the lowest-priced technically acceptable proposal under a firm-fixed-price commercial product contract structure. The solicitation was originally posted on June 11, 2025, with quotes due by July 16, 2025, at 3:00 PM Central Time, and delivery is expected within one month of contract award.
The solicitation is set aside for small businesses under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing), with a small business size standard of 1,000 employees, though businesses of any size may submit quotes. No current contractors or incumbents are identified in the solicitation documents. The contract award value is not specified in the available documentation, but offerors must submit pricing inclusive of shipping costs. The 60,032 glass vials represent a substantial quantity procurement that will be delivered to the Center for Biologics Evaluation and Research (CBER) in Silver Spring, Maryland. The vials must conform to precise dimensional specifications as detailed in the technical drawing provided by SCHOTT for the Vial ABB 5 with American BlowBack design.
Notice text
4 versions
Update #4 · Latest ·
UPDATE 07/09/2025: See attached amendment (-A00001) for the glass vials as small business was not able to meet the requirement with technically acceptable vials that meet the FDA's specifications. The amendment includes updates which are highlighted by a bold line in the left margin of the document showing updated text and clauses, with bold text--and greyed out/stricken text to show deletions. Please ensure you read the instructions to offerors as to what products will be technically acceptable or not. Also note: The previously uploaded specifications are still applicable and do still apply to this amendment.
UPDATE 06/16/2025: Added the specification/drawings for the vials as it was inadvertently left off the original posting.
Original: See attached solicitation for 5 mL glass vials to distribute CBER Reference Standards and Reagents
Update #3 ·
UPDATE 07/09/2025: See attached amendment (-A00001) for the glass vials as small business was not able to meet the requirement with technically acceptable vials that meet the FDA's specifications. The amendment includes updates which are highlighted by a bold line in the left margin of the document showing updated text and clauses, with bold text--and greyed out/stricken text to show deletions. Please ensure you read the instructions to offerors as to what products will be technically acceptable or not. Also note: The previously uploaded specifications are still applicable and do apply to this amendment.
UPDATE 06/16/2025: Added the specification/drawings for the vials as it was inadvertently left off the original posting.
Original: See attached solicitation for 5 mL glass vials to distribute CBER Reference Standards and Reagents
Update #2 ·
UPDATE 06/16/2025: Added the specification/drawings for the vials as it was inadvertently left off the original posting.
Original: See attached solicitation for 5 mL glass vials to distribute CBER Reference Standards and Reagents
Update #1 ·
See attached solicitation for 5 mL glass vials to distribute CBER Reference Standards and Reagents
Files
| File | Type | Posted |
|---|---|---|
| 75F40125Q128395-A00001.pdf | ||
| Specs.pdf | ||
| 75F40125Q128395.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Solicitation | |
| Requirement for 5-mL glass vials for the storage and distribution of CBER Reference Standards and Reagents | Pre-Solicitation |
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