Intent to Sole Source FDA-130321.pdf
PDF 78 KB Posted
- Attached to
- Sprague-Dawley rats (Charles River)
- Solicitation number
- FDA-130321
About this file
This document is a Notice of Intent to Sole Source for the purchase of Sprague-Dawley rats by the FDA's National Center for Toxicological Research (NCTR). The agency intends to award a brand name, firm fixed price purchase order to LI-COR, Inc. for 64 female and 64 male Sprague Dawley rats for protocol E07877.01, and 57 female and 57 male Sprague Dawley rats for protocol E07876.01, to be used in studying the toxicity of tobacco-derived nicotine after repeated inhalation.
The acquisition is specifically restricted to Charles River Laboratories due to their previous involvement in developing the research protocols. The solicitation is classified under NAICS Code 112930 with a small business size standard of $3.75 million. Interested parties may submit a capability statement to Suzanne Martella at suzanne.martella@fda.hhs.gov before July 18, 2025 at 2:00 PM Central Time. If no responsive statements are received, the award will be made to Charles River Laboratories, Inc. under the authority of FAR 13.106-1(b)(1).
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Text version
Purchase of Sprague-Dawley rats Intent to Sole Source
FDA – 130321
Date Posted: July 14, 2025
Response Date: July 18, 2025 2:00 PM CST
Classification Code: 8820 – Live Animals, not Raised for Food
NAICS Code: 112930 - Fur-Bearing Animal and Rabbit Production; with a Small Business Size Standard of $3.75 Million
The U.S. Food and Drug Administration (FDA)/National Center for Toxicological Research (NCTR) intends to award a brand name, firm fixed price purchase order to LI-COR, Inc., 4647 Superior St, Lincoln, NE 68504-1357, under the authority of FAR 13.106-1(b)(1).
The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR)’s requires 64 Female and 64 Male Sprague Dawley Rats for protocol E07877.01 and 57 Female and 57 Male Sprague Dawley Rats for protocol E07876.01 (delivery dates identified below) to access the toxicity of tobacco derived nicotine after repeated inhalation. Both studies will provide robust scientific data that will be used to identify and assess potential public health concerns related to nicotine inhalation exposures. This acquisition is restricted to Charles River Laboratories as these same rats were provided by Charles River for the methods development for the aforementioned approved protocols and it is imperative the lab continues using this specific strain from Charles River to ensure all behavioral testing and scientific data interpretation can be compared in ongoing research. A change in strain and supplier would result in invalidation of the studies of which any initial efforts will essentially be uninformative, unpublishable, nor can the results be used to support regulatory activities.
This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole source contract and is not a request for competitive proposals. The statutory authority for this sole-source procurement is FAR 13.106-1(b)(1).
This notice of intent is not a request for competitive proposals. Interested parties that believes they can meet the requirement, may submit a capability statement to Suzanne Martella at suzanne.martella@fda.hhs.gov before July 18, 2025 at 2:00 pm Central Time (CT). A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. If no responsive statements are received before the closing date and time, an award will subsequently be made to Charles River Laboratories, Inc.
mailto:suzanne.martella@fda.hhs.gov
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