Notice of Intent_Waters.pdf

Food and Drug Administration (FDA) Notice of Intent to Limiting sources

Subject: Fixed Price Contract for the procurement of Waters Aquity I-Class PLUS UPLC System for San Francisco Human and Animal Food Laboratory (SANLHAF).

Notice of Intent to Limiting sources to: Waters Corporation and Waters Corporation authorized 3rd party resellers

Pursuant to the authority of Federal Acquisition Regulation (FAR) Subpart 8.405-6 (a)(i)(1)(B), (only one source is capable of providing the supplies required at the level of quality required because the supplies are highly specialized), the Food and Drug Administration (FDA) intends to award a delivery order to Waters Corporation and Waters Corporation authorized 3rd party.

Waters Corporation 34 Maple Street Milford, MA 01757

FDA has a requirement to obtain Waters Aquity I-Class PLUS UPLC System for San SANLHAF under Request for Quote FDA-RFQ-24-1276632 as a brand name acquisition.

The Waters Acquity UPLC (Ultra-High Performance Liquid Chromatography) System with photo diode array (PDA) detector is specifically required for the implementation of the analytical method LIB (Laboratory Information Bulletin) 4643 “Color Additive Analysis in Foods and Cosmetics using UPLC with Extended Photo-Diode Array Detection” for Colors Analysis within the FDA (The Food and Drug Administration) Agency. All of the FDA field labs that service Colors analysis (Denver laboratory (DENL), San Francisco laboratory (SANLHAF), the New York FDA laboratory (NFFL) and the Atlanta FDA laboratory (SFFL)), have Acquity systems. LIB 4643 has been tested and validated for use with a variety of matrix types and conditions and utilizes the unique technological features (hardware and software) of the Waters Acquity UPLC with the PDA detector.

Implementation and routine use of LIB 4643 requires that all network laboratories use Waters Acquity UPLC Systems with PDA to ensure consistent results, and that facilitate the sharing of critical information to include the FDA spectral reference library).

The use of another brand of Ultra-High Performance Liquid Chromatography) System with photo diode array detector without identical hardware and software capabilities) will require full adaptation, re-method development of the software and hardware for the use of LIB 4643 method for Colors Analysis as well as new training of the field lab network and re-validation of the method. This would introduce a significant delay to the program’s mission and take a minimum of approximately 2 years to achieve, therefore, delaying the advancement of cohesive Colors analysis. Additionally, the use of another Brand-equivalent system would mean that the field network held a mixture of systems which would further lengthen and complicate the analytical process for ensuring equivalence and consistency and a delay in addressing the mission critical need for Colors analysis within the FDA.

The NAICS Code for this procurement is: 334516 - Analytical Instruments

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to Waters Corporation or Waters Corporation authorized 3rd party within approximately fifteen (15) days after the closing date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 3:00 p.m. EST 08/21/2024. Please email responses to Elena Tatarov at Elena.Tatarov@fda.hhs.gov mailto:Elena.Tatarov@fda.hhs.gov