75F40124Q00354_SSN.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) has issued this sources sought announcement on behalf of the Center for Food Safety and Applied Nutrition (CFSAN) Office of Regulatory Science (ORS), Division of Analytical Chemistry (DAC), Method Development Branch (MDB) in order to determine if there are existing small business sources capable of providing three (3) Ultra Performance Liquid Chromatography (UPLC) systems.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Yolanda.rankin@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The Office of Regulatory Science, Division of Analytical Chemistry requires the purchase of three (3) UPLC systems to develop methods that will be useful for analysis of contaminants and additives, including PFAS, in foods and food matrices. The system will be utilized to develop new methods that will be applicable for the FDA laboratories dedicated to food safety.

This instrumentation will be used to develop comprehensive methods for the analysis of contaminants in foods and rapidly analyze a large number of samples to determine contamination.

Minimum Technical Requirements for three (3) Ultra Performance Liquid Chromatography (UPLC) systems:

• Shall include a dual binary pump LC system:

a. Binary high pressure mixing pumps, each with two solvent channels, capable of flow rate range 0.1 - 5000 uL/min.

b. Pumps shall be able to withstand maximum pressures of 105 MPa (~15,000 psi).

• Shall include an autosampler with temperature control from 4-40 ⁰C, 162 position rack, and an external rinse pump.

• Shall include a temperature-controlled column oven with temperature control range from 10 ⁰C below ambient to 100 ⁰C. Column oven should accommodate columns up to 300 mm in length.

• Shall be able to run method files previously developed for a Shimadzu LC system.

• The system shall work seamlessly (single point interface) with Analyst 1.7 software, Sciex OS software, Windows 10 and Applied Biosystems Sciex mass spectrometers.

• Shall be compatible with Sciex Mass Spectrometers such as a 5500+, 6500+ and 7500.

• The Contractor shall ensure compatibility of operation, including system communication and hardware configuration, between the liquid chromatograph and mass spectrometer.

Installation, Training and Warranty Requirements:

• The system and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and trouble shooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration.

• The Contractor shall include a personalized training program. Training shall be web-based and instructor-led at the CFSAN location.

• 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.

• The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

• The Contractor shall install the equipment and provide all labor, travel, kits and tools, etc, to install the equipment at the address provided below, to include inside delivery.

• The Contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization for one day. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures.

• System shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates; unlimited telephone/e-mail support for questions regarding operation, onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA.

Estimated Delivery Date: 30 days after award

Delivery Location:

Food and Drug Administration Center for Food Safety and Applied Nutrition 5001 Campus Drive College Park, Maryland 20740

Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), 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/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Technical Representative and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Though the target audience is small business vendors or small businesses capable of supplying a U.S.

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, DUNS 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 information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, 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 UEI number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/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.

• The offeror shall advise if the product and/or service is on a Best-in-Class contract.

• If applicable, the offeror shall clearly identify where the offered product is made.

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

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or service performance and 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.

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

• Informational pricing is desired.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before June 28, 2024, by 13:00 hours (Central Time in Dallas, Texas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Rankin, email yolanda.rankin@fda.hhs.gov. Reference: 75F40124Q00354.

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.

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 and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality 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.