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UPLC™ Acquity™ High Resolution Columns and Guards
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123A9425Q0003
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This is a Limited Source/Brand Name Justification form from the USDA Food Safety and Inspection Service (FSIS) for procuring UPLC™ Acquity™ High Resolution Columns and Guards from Waters Corporation under FAR 13.106-1(b)(1) for simplified acquisitions. The procurement will be an Indefinite Delivery Indefinite Quantity (IDIQ) contract with a base period and 4 one-year options, with a minimum purchase of $10,000 and maximum ceiling of $500,000 across all periods.

The justification establishes Waters Corporation as the sole source because they are the original equipment manufacturer with no authorized resellers for these specific columns and guards, which are required for USDA-FSIS laboratories to perform regulatory testing and confirmation of antibiotics and drug residues in meat animal tissue. The columns are specified in USDA-FSIS analytical methods and chemistry laboratory guidebook, and substitution would require extensive revalidation of methods, impacting the agency's public health mission. The contract opportunity requires response by January 8, 2025 at 2:00pm EST, with quotes to be submitted to barbara.nelson@usda.gov including pricing and a signed SF1449 form.

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United States Department of Agriculture Limited Source/Brand Name Justification

FAR 13.106-1(b)(1) – Simplified Acquisitions Control No. (if applicable) ________________________

1. Identification of the agency and the contracting activity.

Contracting Activity:

Karen Petty, karen.petty2@usda.gov Contracting Officer USDA, FSIS, Administrative Services Division Procurement Management Branch 5601 Sunnyside Avenue, Maildrop 5230 Beltsville, MD 20705-5230

Requesting Activity:

Matt Hall, matthew.hall@usda.gov , COR USDA, FSIS, Office of Public Health Services, Midwestern Lab 4300 Goodfellow Blvd.

St. Louis, MO 63120

2. Description of supply or service required to meet the agency’s needs.

The USDA-FSIS laboratories seek an Indefinite Delivery Indefinite Quantity (IDIQ) contract with a base and 4 one-year options with Waters Corporation for procuring UPLC™ Acquity™ High Resolution Columns and Guards. The USDA-FSIS laboratories perform regulatory testing and confirmation for antibiotics and drug residue in meat animal tissue. This analytical work is performed using ion trap and triple quadrupole mass spectrometers coupled with liquid chromatographs used for separation and detection of the chemical contaminates. Liquid chromatographs, which separate the chemicals prior to mass spectral analysis, use high resolution columns and guards.

3. The rationale or circumstances for limiting competition.

The columns and guards are specified in the USDA-FSIS analytical methods, listed in the chemistry laboratory guidebook, and cannot be substituted. These methods were developed and validated with the columns listed, therefore changing the manufacturer of the columns would require the validation of a new column for the specified method. This validation work would take time away from the Agency’s mission of protecting public health in order to extend the applicability of the method. This would, additionally, incur additional costs, in both time in and money, to the Agency. Competition is limited to the Waters Corporation because there are currently no re-sellers of the Acquity™ High Resolution Columns and Guard, therefore, Waters is the only approved vendor at this time.

4. A description of the market research conducted and the results or a statement of the reason market research was not conducted.

Market research was not conducted as Waters Corporation is the sole manufacturer of the columns and guards required. Per FAR 13.106-1(b)(1), the Contract Specialist verified with Donna D’Amico, Waters Contract Manager, via a 12/6/2024 email, that Waters is the Original Equipment Manufacturer (OEM) for the Acquity™ High Resolution Columns and Guards. On 12/17/2024, the CS verified with Donna D’Amico, Waters Corporation, that there are no re-sellers for the Acquity Columns and Guards. There are no equivalent options for the columns and guards that will meet the requirements of the labs.

mailto:karen.petty2@usda.gov mailto:matthew.hall@usda.gov

5. Estimated price, including all options, if applicable.

This will be an IDIQ contract, the minimum purchase would be $10,000 and the maximum purchase would be $500,000 inclusive of the base and option periods. $500,000 will be the contract ceiling.

6. Recommended source(s).

The recommended source is Waters Corporation because there are no re-sellers for the UPLC™ Acquity™ High Resolution Columns and Guards.

Certifications

Supporting data that is the responsibility of technical or requirements personnel and which form the basis for this justification are accurate and complete to the best of my knowledge.

Matthew Hall, Contracting Officers Representative

The information contained in this justification is accurate and complete to the best of my knowledge and belief and in accordance with Federal Acquisition Regulation 13.106-1(b)(1), I hereby determine the circumstances described above deem only one source, or limited sources, reasonably available and competition is precluded for the reasons indicated in this document.

Karen Petty, Contracting Officer

United States Department of Agriculture Limited Source/Brand Name Justification FAR 13.106-1(b)(1) – Simplified Acquisitions
1. Identification of the agency and the contracting activity.
Matt Hall, matthew.hall@usda.gov , COR
2. Description of supply or service required to meet the agency’s needs.
3. The rationale or circumstances for limiting competition.
4. A description of the market research conducted and the results or a statement of the reason market research was not conducted.
5. Estimated price, including all options, if applicable.
6. Recommended source(s).
Certifications

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