Solicitation - Notice of Intent to SS.pdf
PDF 69 KB Posted
- Solicitation number
- FDA-CDER-25-128749
About this file
This document is a Notice of Intent to Sole Source issued by the Food and Drug Administration (FDA) on August 11, 2025, for contract number FDA-CDER-25-128749. The FDA intends to award a Firm Fixed Price contract to Lonza Walkersville, Inc. located in Walkersville, MD, under FAR Part 6.302-1, which allows for a sole source procurement when only one responsible source can satisfy agency requirements.
The notice invites alternative vendors to submit capability statements demonstrating they can meet the contract requirements by August 22, 2025, at 3:00 PM EST. Submissions will be reviewed to determine if the government might compete the proposed contract. The FDA anticipates issuing the award to Lonza Walkersville, Inc. within ten days of the notice, unless another organization proves capable of fulfilling the requirements. Specific contract details are referenced in an attached Statement of Work, which was not included in the provided document.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| Requirements Document.pdf |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
August 11, 2025 Notice of Intent to Sole Source
Lonza Walkersville, Inc.
FDA-CDER-25-128749
The Food and Drug Administration (FDA) intends to award a Sole Source Firm Fixed Price contract order to Lonza
Walkersville, Inc. at 8830 Biggs Ford Rd., Walkersville, MD 21793-0127
In accordance with FAR Part 6.302-1 (a) (2)(ii) which states” Only one responsible source and no other supplies or services will satisfy agency requirement”.
The purpose of this notice is to inform the public that the Food and Drug Administration (FDA) anticipates issuing a Firm Fixed Price contract.
MINIMUM REQUIREMENTS:
See Attached Statement of Work
This notice is not a request for competitive proposals. However, any party that believes it can meet this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement.
Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the
Government.
It is anticipated that an award will be issued to Lonza Walkersville, Inc. Within approximately ten (10) days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement.
Response Date: August 22, 2025, by 3.00PM EST. Please email responses to Rodney D. Aytch – rodney.aytch@fda.hhs.gov.
Rodney D. Aytch
Contract Specialist mailto:rodney.aytch@fda.hhs.gov.
File details come from the government source that posted it. Updated .