Notice of Intent to Sole Source: Miniature Swine Cognition Test Systems

The U. S. Food and Drug Administration (FDA) intends to award a sole source, firm fixed-price contract to Med Associates Inc., P.O. Box 319 St Albans, VT 05478-0319, under the authority of FAR 13.106-1(b)(1).

Background: The FDA, National Center for Toxicological Research (NCTR), Division of Neurotoxicology (DNT) requires Miniature Swine Cognition Test Systems for future studies. These systems must be compatible with the existing system, Med Associates, Inc., MedTouch. It must use plug and play hardware that is compatible with existing Med Associates hardware.

It must use K-Limbic software that can use executable/program files generated in the existing system with little modification, and it must use K-Limbic screens that are compatible with the existing system. Since the 1980’s, NCTR has been a leader in using animals to model neurotoxicity. Historically, some of our highest impact work has been performed using nonhuman primates (NHPs), an unparalleled model of human development.

However, NHPs are becoming increasingly difficult and costly to source, and extensive safety measures are required for their safe use. Additionally, there is a desire to limit their use in biomedical research owing to ethical concerns. For these reasons, NCTR is planning to transition some of its future studies to the miniature swine. To do this will require the ability to perform cognitive assessments in the miniature swine.

NCTR/DNT current NHP and rodent systems are not appropriate for adaptation to the miniature swine. Most existing swine testing systems either make use of “farmyard” methods (not appropriate in a toxicology setting), require an experimenter to run them (low throughput and prone to bias), or have them respond with their hoof (unnatural response for the animal and will quickly destroy the apparatus). These systems are inappropriate for our needs.

This SOW is for a “touchscreen” based automated cognition testing system that will allow animals to respond to visual and auditory stimuli with their nose for a food pellet reward. This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(1) 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. Responsible sources who believe they can meet the requirement, may submit a capability statement to Jennifer Johnson at jennifer.johnson3@fda.hhs.gov on or before June 20, 2024, at 12:00 pm Central Standard Time (CT). A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No phone call will be accepted.