9 CFR § 104.2 - Permit authorized.
(a) Animal and Plant Health Inspection Service is authorized to issue three types of permits for importing biological products. They shall be:
(1) U.S. Veterinary Biological Product Permit for Research and Evaluation;
(2) U.S. Veterinary Biological Product Permit for Distribution and Sale; or
(3) U.S. Veterinary Biological Product Permit for Transit Shipment Only.
(b) A permit shall not be issued for a biological product from countries known to have exotic diseases, including but not limited to foot-and-mouth disease, highly pathogenic avian influenza, swine vesicular disease, Newcastle disease, and African swine fever, if in the opinion of the Administrator, such products may endanger the livestock or poultry of this country.
(c) A permit shall not be issued until an inspector has determined the condition of the equipment and facilities of the producer, of the applicant, or of both if such a determination is considered necessary by the Administrator.
(d) A permit shall not be issued for a biological product prepared in the United States, exported, and presented for reentry except as provided in § 104.4(d).