Notice of Intent to SS _1238981.pdf

February 22, 2021

Notice of Intent to Sole Source

1260 Infinity II Multi‐Detector GPC/SEC System with a 1260 Infinity II HPLC

FDA_SS_1238981

The Food and Drug Administration (FDA) intends to award a Sole Source firm‐fixed price purchase order to Agilent Technologies, 5301 Stevens Creek Boulevard, Santa Clara, CA 95051. In accordance with FAR part 6.302‐1, the contractor is the only responsible source who can provide the required services as no other source has been identified to satisfy the agencies requirements.

The purpose of this notice is to inform the public that the FDA anticipates issuing an award to procure one

(1) 1260 Infinity II Multi‐Detector GPC/SEC System with a 1260 Infinity II HPLC to create a dedicated HPLC system at DPA and DCDA for SEC/GPC application with a detector and software specific to molecular weight determinations. The multi‐detector and associated software must be compatible with the HPLC, as well as with previous data collected on standalone Agilent RI detectors. In addition, the multidetector software must be able to integrate with the HPLC and control it during analysis.

The associated North American Industrial Classification System (NAICS) Code is 334516: Analytical Laboratory Instrument Manufacturing.

A. Minimum HPLC Technical Salient Characteristics:

1. Shall provide newly manufactured unit, not used, refurbished or previously used for demonstration.

2. Shall provide a maximum backpressure capability of 400 bars or higher.

3. Shall have a maximum flow rate of 3 mL/min or higher.

4. Shall have a maximum column temperature of 80 °C or higher.

5. Shall have a built‐in solvent degassing, at least 4 channels

6. Shall have an autosampler with minimum injection volume of 100 µL

7. Shall have a variable wavelength detector with frequency up to 120 Hz

8. Shall have the ability to be controlled by Chemstation OpenLab using DPA’s existing server network

9. HPLC must include delivery, installation, and IQ/OQ.

B. Minimum MD Technical Salient Characteristics:

1. Shall provide newly manufactured unit, not used, refurbished or previously used for demonstration.

2. Shall be compatible with the HPLC system.

3. Shall provide software associated with the MD

4. Shall have the ability to operate the HPLC and the MD system described above simultaneously.

5. Shall provide software to analyze molecular weight distributions from refractive index and ultraviolet data collected on other existing Agilent detectors.

6. Shall have the ability to be capable of refractive index detection, multi‐angle light scattering detection (dual angle at minimum), and viscometry detection.

C. Minimum Training Requirements:

1. Shall provide an overview of instrument and instructions for basic care and upon installation for Multi‐Detector and software.

2. Shall have the training taught by a service engineer who is trained and certified.

3. Shall be scheduled by the Contracting Officer Representative (COR) after installation is deemed by the COR or to be operationally acceptable.

D. Minimum Warranty Requirements:

1. Shall include one (1) year warranty for parts and labor from the date of acceptance.

2. Shall include all shipping, installation, travel, labor, and parts required at no additional cost to the government.

3. Shall provide pricing for extending warranty beyond the one (1) warranty.

This notice is not a request for competitive proposals. However, any party that believes it can meet 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 Agilent Technologies, within approximately ten (10) days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement.

Response Date: March 3, 2021 by 10:00AM Eastern Time. Please email responses to Nicole Craig at nicole.craig@fda.hhs.gov. No phone calls will be accepted.