Advanced Freeze-Dryer Sources Sought
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA) is conducting market research through a Sources Sought notice to identify providers for an Advanced Freeze-Dryer with specific capabilities. This is for planning purposes to determine potential set-asides or competition types for a future requirement. Capability statements are due by February 10, 2025, at 1:00 PM CT.
Purpose & Overview
This notice, identified as 75F40126SS131701, is solely for market research and is not a request for proposal or solicitation. The FDA aims to assess industry capabilities and availability for an Advanced Freeze-Dryer to support complex generics, biologics, and essential medicine manufacturing, facility inspections, staff training, and guidance development. Responses will inform the Government's decision on whether to pursue a small business set-aside, full and open competition, or a sole-source acquisition.
Key Requirements
The FDA is seeking an Advanced Freeze-Dryer featuring foam drying and controlled ice nucleation capabilities, advanced process monitoring and control, and integration with digital twin technology and AI-based process control strategies. The equipment must be "Made in America" in accordance with Executive Order 14005. Specific items include:
- Item 1: Laboratory Scale R&D Lyophilizer Controlled Ice Nucleation and Foam Drying Ready
- Item 2: Tunable Diode Laser Absorption Spectroscopy (TDLAS) System
- Item 3: Warranty, Delivery, Installation, and On-site Training
Submission Details
Interested parties must submit capability statements via email to howard.nesmith@fda.hhs.gov by 1:00 PM Central Time on February 10, 2025. Submissions should include:
- Proposed Product Information and Description
- Capability Statement confirming "Made in America" status
- Business Name, DUNS Number, Business Address, Website, and Size Status
- Business Contact Information
- NAICS Small Business Program Representations
- Country of Origin (if not Made in America) Informational pricing is encouraged but not mandatory. Proprietary, classified, or sensitive information should not be included.
Eligibility / Set-Aside
The target audience is Small Business Manufacturers or Small Businesses capable of supplying services under NAICS 334516 (Laboratory Equipment And Supplies). However, all interested parties, regardless of size or NAICS code, are encouraged to respond to assist the FDA's market research efforts.
Important Notes
This is not a request for quote or proposal, and responses will not be considered adequate responses to a solicitation. The Government reserves the right to use non-proprietary technical information from responses in future solicitations.