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Vacinnes, Immunotoxins, Medical Products, Diagnostic & Food Testing Kits

Export Control Classification Numbers (ECCN): IC991

* This is a list of controls that may be applicable to investigators at University of Colorado. It is by no means an exhaustive list and should not be used as an assurance that your research is not subject to export controls. 

Related Definitions: For the purpose of this entry, “immunotoxin” is defined as an antibody-toxin conjugate intended to destroy specific target cells (e.g., tumor cells) that bear antigens homologous to the antibody.  For the purpose of this entry, “medical products” are: (1) pharmaceutical formulations designed for testing and human administration in the treatment of medical conditions, (2) prepackaged for distribution as clinical or medical products, and (3) approved by the U.S. Food and Drug Administration either to be marketed as clinical or medical products or for use as an “Investigational New Drug” (IND) (see 21 CFR Part 312). For the purpose of this entry, “diagnostic and food testing kits” are specifically developed, packaged and marketed for diagnostic or public heath purposes.  Biological toxins in any other configuration, including bulk shipments, or for any other end-users are controlled by ECCN 1C351 or ECCN 1C360. For the purpose of this entry, “vaccine” is defined as a medicinal (or veterinary) product in a pharmaceutical formulation, approved by the U.S. Food and Drug Administration or the U.S. Department of Agriculture to be marketed as a medical (or veterinary) product or for use in clinical trials, that is intended to stimulate a protective immunological response in humans or animals in order to prevent disease in those to whom or to which it is administered.

List of Controlled Items

  • Vaccines against items controlled by ECCN 1C351, 1C352, 1C353, 1C354, 1C360
  • Immunotoxins containing items controlled by 1C351.d
  • Medical products containing botulinum toxins controlled by ECCN 1C351.d.3 or conotoxins controlled by ECCN 1C351.d.6
  • Medical products containing items controlled by ECCN 1C351.d. (except botulinum toxins controlled by ECCN 1C351.d.3, conotoxins controlled by ECCN 1C351.d.6, and items controlled for CW reasons under 1C351.d.11 or .d.12)
  • Diagnostic and food testing kits containing items controlled by ECCN 1C351.d. (except items controlled for CW reasons under ECCN 1C351.d.11 and .d.12)

 

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