Sources Sought Notice HFP-2025-129689.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

Ultra-high performance liquid chromatography (UPLC) system for a Thermo Scientific

Q-Exactive (QE) to support method development for economic adulteration

HFP-2025-129689

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Office of Laboratory Operations and Applied Science (OLOAS), Office of Chemistry and Toxicology (OCT), Division of Analytical Chemistry (DAC), and Method Development Branch (MDB).

The FDA Office of Chemistry and Toxicology, Division of Analytical Chemistry requires the purchase of one ultra-high performance liquid chromatography system to replace end-of-life devices with the option to buy two (2) additional systems to develop methods that will be useful for analysis of contaminants and additives, including polyfluoroalkyl substances (PFAS), in foods and food matrices.

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required service/product. Other Than Small Business (OTSB) concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is – 334516 - Analytical Laboratory Instrument Manufacturing. The applicable Small Business Size Standard is 1,000 employees.

Statement of Work See below.

Alternative Solutions Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements.

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

Response Instructions Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

• Section 1: Respondent Overview

- Business name, SAM Unique Entity ID 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.

• Section 2: Descriptive Information

- Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including technical specifications, ISO certifications, descriptive material, literature, brochures, and other information, which demonstrates the capabilities of the contractor to meet the requirement.

• Section 3: Past Performance

- Three (3) years of past performance service information, if not the manufacturer of the equipment identified herein, where the respondent has provided same or substantially similar service solutions on the same or near-same brand name equipment.

- For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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 SAM Unique Entity ID number and size status) if not the respondent.

• Section 4: Capabilities and Delivery

- The offeror’s capability to meet the delivery requirements within the time specified above.

- Offeror shall provide estimated historical on-site response time from the initial call for service until a service technician was on-site for the brand name and model of instrument in this solicitation or a standard target time for onsite performance from initiation of service call.

- If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.

- 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.

- Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein.

Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards.

The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).

- Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.

- If a large business, identify the subcontracting opportunities that would 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; and

- Though this is not a request for quote, informational pricing is encouraged for both the purchase of the instrument and a lease of the instrument.

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

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before July 24, 2025 by 13:00 hours (Central Time in Jefferson, Arkansas) to david.kramer@fda.hhs.gov.

Reference HFP-2025-129689

Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition, or procure through sole-source acquisition procedures.

http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/policy/accessibility http://www.itic.org/policy/accessibility

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).

Statement of Work

Ultra-high performance liquid chromatography (UPLC) system for a Thermo Scientific Q-Exactive (QE) to support method development for economic adulteration

HFP-2025-129689

1. Purpose:

The purpose of this requirement is to purchase a liquid chromatograph (LC) system for the Office of Laboratory Operations and Applied Science (OLOAS), Office of Chemistry and Toxicology (OCT), Division of Analytical Chemistry (DAC), and Method Development Branch (MDB).

2. Background:

The Office of Chemistry and Toxicology, Division of Analytical Chemistry requires the procurement of a liquid chromatography system to develop methods that will be useful for analysis of contaminants and additives, including polyfluoroalkyl substances (PFAS) in foods and food matrices.

This need is to develop new methods that will be applicable for the Food and Drug Administration (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 many samples to determine contamination. The instruments will serve as an inlet for previously purchased Sciex mass spectrometers as well as a Thermo Scientific Q-Exactive HF Orbitrap (QE-HF).

3. Objectives:

The objective of this requirement is to purchase one (1) liquid chromatograph system with the option to purchase two (2) additional systems to support the Agency’s mission.

The system shall be newly manufactured unit, not used or refurbished, or previously used for demonstration. The instrument shall meet all delivery requirements specified listed below.

1) The Contractor shall deliver and install the instrument. The HFP TPOC will perform inspection and acceptance of the mass spectrometer system.

2) The Contractor shall demonstrate upon installation that the item shall meet all performance specifications by the manufacturer.

3) The Contractor shall ensure compatibility of operation, including system communication and hardware configuration, between the liquid chromatograph and mass spectrometer (Sciex mass spectrometers as well as a Thermo Scientific Q- Exactive HF Orbitrap (QE-HF).

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

4. Salient functional/performance characteristics:

The Contractor shall provide instruments that meet the following technical salient functional/performance characteristics:

1) Ultra-high performance liquid chromatography system with the following requirements:

a) Dual binary pump LC system

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

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

iii) The solvent delivery unit must be of parallel dual plunger micro-volume (10 uL stroke) construction.

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

c) 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.

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

e) Shall work seamlessly (single point interface) with Sciex OS software (version

3.4), Windows 10 and Thermo Scientific Foundations 3.1 SP4 and Excalibur 4.1.31.9.

f) Shall be compatible with Sciex Mass Spectrometers such as a 5500+, 6500+ and 7500 as well as a Thermo Scientific QE-HF Orbitrap.

g) Minimum one (1) year warranty on parts, labor, and travel.

5. Deliverables:

1) The Contractor shall deliver and install the instrument and all components specified above to the FDA/HFP laboratory facility located at 5001 Campus Drive, College Park, MD 20740.

2) If the Contractor is not installing on the day of delivery, the delivery shall be made to the loading dock and moved into location on the date of installation.

3) The Contractor shall demonstrate upon installation that the item will meet all performance specifications by the manufacturer. The instrument shall not be accepted until those performance specifications have been met.

4) The HFP TPOC/COR will perform inspection and acceptance of the ultra-high performance liquid chromatograph system.

5) Entire system shall be warranted under a commercial warranty for parts and labor for one (1) year from date of acceptance, including one preventative maintenance (PM) visit to occur approximately 1-3 months before the original warranty expires.

6) Service and installation shall be provided by service engineers who are trained and certified by the original manufacturer of the instrument.

7) Engineers should have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

8) A one (1) day on-site training program for FDA users will be arranged by the HFP

TPOC/COR.

6. Government-Furnished Property, Material, Equipment, or Information

(GFP, GFM, GFE, or GFI) N/A

7. Contractor Provided Special Material Requirements

8. Security

9. Travel Service contract shall include all travel by the contractor to the stated Place of Performance.

10. Place of Performance The work shall be performed at FDA/HFP, 5001 Campus Drive, College Park, Maryland, 20740. Delivery and installation of the instrument and all components specified above shall be coordinated through the HFP TPOC.

11. Period of Performance Delivery shall be made prior to DATE TBD. The entire system shall be warranted for parts and labor for twelve (12) months from date of installation.

12. Holidays and Government Closures The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

• New Year’s Day

• Martin Luther King Day

• President’s Day

• Memorial Day

• Juneteenth Independence Day

• Independence Day

• Labor Day

• Columbus Day

• Veteran’s Day

• Thanksgiving Day

• Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

13. Contract Administration Technical Point of Contact (POC):

• To be provided at time of award.