SSN 75F40126SSN132651.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY

COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS

ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought Notice (SSN) on behalf of the Office of the Chief Scientist (OCS), San Juan Medical Products Laboratory (SJNLMP) in order to determine if there are existing small business sources capable of providing a Karl Fischer Titrator (KFT) or equivalent system to replace an older KFT system which is used to analyze medical product samples using specific protocols and methods established by USP, internal FDA programs, DOD SLEP, and the FCC program. The instrument shall meet or exceed the requirements listed below.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees, and you believe that your firm would be able to provide the FDA with the product described below, please submit an email to suzanne.martella@fda.hhs.gov.

Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum specifications included below—to include the country of manufacture of products offered.

1. The system shall comply with the following quality requirements:

a. ISO/IEC 17025-2017 https://www.iso.org/standard/39883.html, https://www.iso.org/standard/66912.html

b. ISO 9001:2008 https://www.iso.org/standard/46486.html

c. 21 CFR Part 11 Compliance Features Available https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

d. USP, cGMP/cGLP https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flo gin mailto:suzanne.martella@fda.hhs.gov https://www.iso.org/standard/39883.html,%20https:/www.iso.org/standard/66912.html https://www.iso.org/standard/39883.html,%20https:/www.iso.org/standard/66912.html https://www.iso.org/standard/46486.html https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin

Minimum Requirements/Specifications:

The system shall:

1. Be a modular design.

2. Be controlled by instrument controller software.

3. Include a Dynamic Dosing Unit.

4. Include a titration stand with magnetic stirrer and built-in pump.

5. The pump shall be able to aspirate the titered-out solution and to add a new solvent without having to open the titration cell.

6. Include a titration vessel and stirring bar.

7. Include solvent and waste bottles.

8. Be equipped with four MSB connectors.

9. Include a 10 mL and 20 mL high-resolution burettes.

10. Include a USB/RS-232 Converter for balance connections

11. To Integrate the existing balance in San Juan laboratory from Mettler Toledo.

Workstation Requirements:

1. The system shall include a complete workstation running Windows 11, and at a minimum:

a. Processor: Intel I7 or equivalent

b. Minimum of 16 GB RAM

c. 256 GB SSD Hard Drive

d. Keyboard and Mouse

e. Monitor

f. Ports options such as USB and Ethernet

2. The system shall include the latest Instrument Controller Software with its instrument license and current firmware.

Delivery, Installation, Training and Additional System Requirements:

1. The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

2. Offered systems shall be a turn-key solution i.e., the Contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.

3. The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The system shall be delivered with all necessary supplies, accessories, and standard kits required for installation, start-up, and qualification tests.

4. Installation shall be conducted by factory certified service personnel, who shall demonstrate that all modules start up properly, are correctly installed and connected.

5. The systems shall include onsite Installation Qualification (IQ), and Operational Qualification (OQ) for the hardware and instrument controller software. Qualifications test shall be reviewed and approved by an FDA representative before/after installation of the equipment and execution of protocols. Qualification reports shall include the standard operating procedures and the allowed manufacturer limits for the instrument. Also, qualification tests shall meet Chapter 21 CFR part 11 requirements. All documentation shall be provided in electronic format.

6. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format.

7. Upon acceptance of the system, the Contractor shall provide on-site operator training/familiarization for 3-5 users. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures.

8. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty shall be included with the equipment and not separately priced. Warranty services shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, immediate access to system improvements and updates, labor and travel costs. Phone and email technical support shall be included for a minimum of one (1) year.

9. System shall include a preventative maintenance (PM) approximately 11 months after the date of purchase to ensure the instrument is functioning at peak performance.

Service Records and Reports: The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service call), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the service, and for information purposes, the on-site hours expended, and parts/components replaced.

Delivery Terms: Delivery, installation, qualification test, and training are expected to be completed within 90 days of contract award at the below address:

Food and Drug Administration San Juan Medical Products Laboratory 466 Fernandez Juncos Ave, San Juan, PR 00901-3223

POC: will be appointed and contact information will be given upon contract award.

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar services. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, Unique Entity ID (SAM) number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product to include date of sale, description of services provided, contract dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include Unique Entity ID (SAM) number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of what the responding firm is regularly engaged in manufacturing or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above.

• If applicable, identification of the firm’s GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

• If a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of manufacture or any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

• Though this is not a request for quote, informational pricing for the products would be helpful for market research purposes.

The Government is not responsible for locating or securing any information not identified in the response.

Interested Contractors must respond with capability statements which are to be submitted by email only to the point of contact listed below on or before 3:00 pm (Central Time in Jefferson AR) on February 4, 2026 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40126SSN132651.

mailto:suzanne.martella@fda.hhs.gov

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Responses with weblinks will not be opened or viewed.

Responses must demonstrate capability, not merely affirm the respondent's capability (i.e. the response must go beyond the statement that, "XYZ company can provide the instrument, technical support etc.").

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

After a review of the responses received, a pre‐solicitation synopsis or combined synopsis/ solicitation may be published in SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information

No proprietary, classified, confidential, or sensitive information should be included in your response.

The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.