160 kV X-Ray Cabinet System

ID: RFQ_75F40123Q00183 • Type: Synopsis Solicitation

Description

Posted: July 19, 2023, 2:38 p.m. EDT

*********Amendment A00002************

The Purpose of this Amendment is to do the following:

1) To extend the RFQ closing date from 7/20/2023 to 7/21/2023 10AM ET.

All other terms and conditions reamin unchaged.

*********Amendment A00001************

The Purpose of this Amendment is to do the following:

1) To extend the RFQ closing date from 7/17/2023 to 7/20/2023.

2) To provide questions and responses as attachment labeled "75F40123Q00183_A00001_Questions and Answers."

All other terms and conditions reamin unchaged.

Posted: July 14, 2023, 1:30 p.m. EDT

Posted: June 30, 2023, 2:29 p.m. EDT

Background
The U.S. Food and Drug Administration (FDA) has a need to procure one (1 each) 160 kV X-Ray Cabinet System that is compatible with MXR-160/22 COMET X-Ray tube along with one (1 each) stationary optical table. The Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), in the Division of Imaging, Diagnostics and Software Reliability (DIDSR), at one of many research labs, FDA has an X-Ray facility that is used to generate a polychromatic x-ray beam at various tube voltage and current. The 160 kV X-ray Cabinet System is required to perform spectroscopic measurements and bench testing of emerging spectral x-ray imaging technologies using photon-counting detectors and polychromatic x-rays. DIDSR’s long-term goal is to explore the benefits and advantages of using emerging spectral imaging technology. FDA’s current X-Ray cabinet system needs to be replaced due to the radiation leakage and inability to pre-collimate or filter the x-ray beam. This purchase will enable FDA to continue developing evaluation methods for these emerging technologies at various x-ray beam settings that will be useful for future regulatory submissions.

Work Details
The Vendor shall provide a newly manufactured 160 kV X-Ray Cabinet system that is compatible with industrial x-ray tubes, including the MXR-160/22 COMET X-Ray tube, not used or refurbished or previously used for demonstration. The system should have a shielded housing with less than 5 mR/hr radiation leakage at the surface of the cabinet at a maximum output voltage of 160 kVp and a maximum current of 19 mA. It should be compatible with the existing x-ray generator with controller (iVario160, COMET) and the water cooler (Cooler XRC-3023-WW, COMET). The X-ray beam opening should be at 58-inch height from the lab floor. Additionally, it should include a beam shutter, two identical aperture wheels, a new MXR-160/22 COMET X-Ray tube, five meter High Voltage Cable with connector type R24, standing vertically on the floor and bolted to the floor to avoid tip over, not exceed the overall dimension of 30-inch (length) x 30-inch (width) x 75-inch (height) and the weight of 1000 lb.

Period of Performance
120 Days after Receipt of Award (DARO), plus 12-month warranty. June 2023 – October 2024

Place of Performance
U.S. Food and Drug Administration WO62-4135, 10903 New Hampshire Ave. Silver Spring, MD 20993

Overview

Agency

Food and Drug Administration (FDA) [HHS]

Response Deadline

July 21, 2023, 10:00 a.m. EDT (original: July 17, 2023, 10:00 a.m. EDT) Past Due

Posted

June 30, 2023, 2:29 p.m. EDT (updated: July 19, 2023, 2:38 p.m. EDT)

Set Aside

Small Business (SBA)

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

PSC

6640 - Laboratory Equipment And Supplies

Place of Performance

Silver Spring, MD 20993 United States

Source

SAM

Current SBA Size Standard

1000 Employees

Pricing

Likely Fixed Price

Evaluation Criteria

Best Value

Est. Level of Competition

Low

Signs of Shaping

79% of obligations for similar contracts within the Food and Drug Administration were awarded full & open.

On 6/30/23 Food and Drug Administration issued Synopsis Solicitation RFQ_75F40123Q00183 for 160 kV X-Ray Cabinet System due 7/21/23. The opportunity was issued with a Small Business (SBA) set aside with NAICS 334516 (SBA Size Standard 1000 Employees) and PSC 6640.

Primary Contact

Name

Heather Kinsey Profile

heather.kinsey@fda.hhs.gov

Phone

(240) 402-7591

Question & Answer

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Additional Details

Source Agency Hierarchy

HEALTH AND HUMAN SERVICES, DEPARTMENT OF > FOOD AND DRUG ADMINISTRATION > FDA OFFICE OF ACQ GRANT SVCS

FPDS Organization Code

7524-00223

Source Organization Code

100188033

Last Updated

Aug. 5, 2023

Last Updated By