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Special notice

Sprague-Dawley rats (Charles River)

FDA-130321

Food and Drug Administration, FDA Office of Acq Grant SVCS. Fur-Bearing Animal and Rabbit Production.

View on SAM.gov Markdown

Response deadline

July 18, 2025 at 3:00 PM EDT

Closed 473 days ago. Posted July 14, 2025. Scheduled to archive August 2, 2025.

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Description

As published on SAM.gov.

See attached Notice of Intent to Sole Source requirement for Sprague Dawley rats for protocols: E07877.01 and E07876.01 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.

Publications

Every notice SAM.gov issued under this solicitation number, oldest first. Each is a separate record on SAM.

  1. July 14, 2025

    Special notice, originally combined synopsis and solicitation

    Due July 18, 2025 at 3:00 PM EDT. SAM.gov, notice 35f9b14ce93b44a1b327bb62ee2599e5

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