NOI - Sole Source Single Lab Validation.doc

FDA-Sole Source-1229037

Intends to make a sole source award:

The Food and Drug Administration (FDA) Center for Food Safety and Nutrition (CFSAN) requires a development and validation of a method for the detection of shigatoxigenic E. coli (STEC) in sprout irrigation water (SIW).

The award will be made to:

Dr. Willis M. Fedio

Director, Food Safety Laboratory & Assoc. Professor

New Mexico State University

Center for Animal Health and Food Safety

PO Box 30003

Las Cruces, NM 88003 In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The Center for Food Safety and Nutrition (CFSAN) requires a development and validation of a method for the detection of shigatoxigenic E. coli (STEC) in sprout irrigation water (SIW).

Since December 2018, the New Mexico State University (NMSU) Food Safety Laboratory (FSL), under the leadership of Dr. Willis Fedio, has conducted 15 SIW method evaluation studies and has completed the testing with mung bean SIW. NMSU FSL was supported by FDA’s FERN Microbiology Cooperative Agreement Program (CAP) program (see pages 6 – 8 of attached EOY Report). Dr. Fedio has been instrumental in the development of a method for the detection of STECs in SIW during the last year and a half. We are now at the point where we can validate the method, so that it can be used by FDA Food and Feed Laboratories and by commercial testing laboratories, but the CAP Program is being replaced with a Flexible Funding Model in support for this methods development/validation project (see Discipline D: Special Projects; https://grants.nih.gov/grants/guide/pa-files/PAR-20-105.html).

FDA has no fully validated methods for STECs in sprouts or in SIW, yet commercial sprouters, who are regulated under FSMA, are required to test their products for STECs. A sole source contract with Dr. Fedio’s laboratory will correct this deficiency.

Dr. Willis M. Fedio, Director, Food Safety Laboratory & Assoc. Professor, New Mexico State University is the only contractor that can provide FDA with Single Lab Validation of a Method for the Detection of Shigatoxigenic E. coli in Sprouts.

This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within twelve (12) days after the publication of this synopsis which shall be considered by the agency. Responses received after 12 days or without the required information may not be considered. For information concerning this acquisition contact:

Tara Hobson

Contract Specialist Email: Tara.Hobson@fda.hhs.gov No phone calls please A determination by the Government not to compete because of information received is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement.

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