NOI SS 1229074.pdf

75F40120Q00076

Notice of Intent to Sole Source for

Core Support to Produce Animal Nutrition Reports

The Food and Drug Administration (FDA), the Office of Acquisitions and Grants Services (OAGS) intends to inform the public that the FDA anticipates issuing an award to procure the maintenance of the PANalytical Axios Wavelength-Dispersive X-Ray Fluorescence (XRF) Spectrometer. The Period of Performance includes a one-year Base Period and 4 annual Option Periods. The X-Ray Fluorescence (XRF) Spectrometry is used to analyze samples of color additives (synthetic dyes) that are used in foods, drugs, cosmetics and medical devices for elements with limiting specifications listed in 21 CFR Part 74. XRF is the primary means of analysis used to determine levels of these materials in the range of 1 – 1000 ppm. XRF is also used for official sample analyses when elemental composition is being determined. Reliable and timely maintenance and repair of this instrument is critical to the mission of the Color Certification Branch which is to certify color additives for use in foods, drugs, cosmetics and medical devices.

In accordance with FAR part 6.302-1, Malvern Panalytical, Inc. is the only known responsible source who can provide the required services as no other source has been identified who can provide the requirements listed below.

The FDA intends to award a purchase order to Malvern Panalytical, Inc. located at 117 Flanders Road Westborough, MA 01581.

TECHNICAL REQUIREMENTS:

The request for a new service agreement will include 48-hour on-site response time during normal business hours, unlimited labor and travel during normal business hours, and unlimited emergency calls. The Contractor will provide same day telephone support, and when needed next work day on site service on all the equipment specified in the contract.

Repair parts (except the x-ray tube) are to be provided at no cost and will be covered under the contract for future replacement if necessary. Repair parts must be genuine PANalytical parts and be installed within 2 days of the service visit. All technicians both service and phone support must be PANalytical certified.

This notice is not a request for competitive quotes. However, any party that believes it is capable of meeting the requirements as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. A determination by the Government to compete this proposed award based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued within approximately seven (7) days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement.

Please email responses to Janae Hughes at janae.hughes@fda.hhs.gov. No phone calls will be accepted.

mailto:janae.hughes@fda.hhs.gov