Legitimate Needs Form: FRM-SAT-012

The possession, use, and transfer of botulinum neurotoxins in the United States is governed by the provisions set forth by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. In accordance with The Code of Federal Regulations Title 42 Part 73.3(d)(7), botulinum neurotoxins of an aggregate amount no greater than 1 mg may be transferred to a recipient that does not possess a certificate of registration issued by the Secretary of the Department of Health and Human Services and/or the Administrator, Animal and Plant Health Inspection Service provided that (1) “…the aggregate amount of toxin under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor does not, at any time, exceed…1 mg of Botulinum neurotoxins”; (2) “…legitimate need (e.g., prophylactic, protective, bona fide research, or other peaceful purpose)…[is] claimed by the recipient to use such toxin”; (3) the transferor “[r]eports to CDC if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to [the] toxin”.

I certify that: (1) the information provided above is true and correct; (2) the aggregate amount of botulinum neurotoxins under my control shall not exceed 1 mg (recipients in the United States) or any other such applicable possession limits (recipients outside of the United States) as a result of receipt of the toxin requested herein; (3) I understand that the toxins requested herein are for research use only, are not for use in humans, and may not be reprocessed, repackaged, or resold.