[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1240.63]

[Page 699-700]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1240_CONTROL OF COMMUNICABLE DISEASES--Table of Contents
 
    Subpart D_Specific Administrative Decisions Regarding Interstate 
                                Shipments
 
Sec. 1240.63  African rodents and other animals that may carry 
the monkeypox virus.

    (a) What Actions Are Prohibited? What Animals Are Affected? (1) 
Except as provided in paragraph (a)(2) of this section,
    (i) You must not capture, offer to capture, transport, offer to 
transport, sell, barter, or exchange, offer to sell, barter, or 
exchange, distribute, offer to distribute, or release into the 
environment, any of the following animals, whether dead or alive:
    (A) Prairie dogs (Cynomys sp.),
    (B) African Tree squirrels (Helioscirurus sp.),
    (C) Rope squirrels (Funisciurus sp.),
    (D) African Dormice (Graphiurus sp.),
    (E) Gambian giant pouched rats (Cricetomys sp.),
    (F) Brush-tailed porcupines (Atherurus sp.),
    (G) Striped mice (Hybomys sp.), or
    (H) Any other animal so prohibited by order of the Commissioner of 
Food and Drugs because of that animal's potential to transmit the 
monkeypox virus; and
    (ii) You must not prevent, or attempt to prevent, the Food and Drug 
Administration (FDA) from causing an animal to be quarantined or 
destroyed under a written order for the animal's quarantine or 
destruction.
    (2) The prohibitions in paragraph (a)(1) of this section do not 
apply if you:
    (i) Transport an animal listed in paragraph (a)(1) of this section, 
or covered by an order by the Commissioner of Food and Drugs, to 
veterinarians or animal control officials for veterinary care, 
quarantine, or destruction purposes; or
    (ii) Have written permission from FDA to capture, offer to capture, 
transport, offer to transport, sell, barter, or exchange, offer to sell, 
barter,

[[Page 700]]

or exchange, distribute, offer to distribute, and/or release into the 
environment an animal listed in paragraph (a)(1) of this section, or 
covered by an order by the Commissioner of Food and Drugs. You may not 
seek written permission to sell, barter, or exchange, or offer to sell, 
barter, or exchange, as a pet, an animal listed in paragraph (a)(1) of 
this section or covered by an order by the Commissioner of Food and 
Drugs.
    (A) To obtain such written permission from FDA, you must send a 
written request to the Division of Compliance (HFV-230), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, Attn: Listed Animal Permit Official. You may also 
fax your request to the Division of Compliance (using the same address 
in the previous sentence) at 301-827-1498.
    (B) Your request must state the reasons why you need an exemption, 
describe the animals involved, describe the number of animals involved, 
describe how the animals will be transported (including carrying 
containers or cages, precautions for handlers, types of vehicles used, 
and other procedures to minimize exposure of animals and precautions to 
prevent animals from escaping into the environment), describe any 
holding facilities, quarantine procedures, and/or veterinarian 
evaluation involved in the animals' movement, and explain why an 
exemption will not result in the spread of monkeypox within the United 
States.
    (C) We (FDA) will respond, in writing, to all requests, and we also 
may impose conditions in granting an exemption.
    (b) What Actions Can FDA Take? (1) To prevent the monkeypox virus 
from spreading and becoming established in the United States, we may, in 
addition to any other authorities under this part:
    (i) Issue an order causing an animal to be placed in quarantine,
    (ii) Issue an order causing an animal to be destroyed, or
    (iii) Take any other action necessary to prevent the spread of the 
monkeypox virus.
    (2) Any order to cause an animal to be placed in quarantine or to 
cause an animal to be destroyed will be in writing.
    (c) How Do I Appeal an Order? (1) If you receive a written order to 
cause an animal to be placed in quarantine or to cause an animal to be 
destroyed, you may appeal that order. Your appeal must be in writing and 
be submitted to the Food and Drug Administration District Director whose 
office issued the order, and you must submit the appeal within two 
business days after you receive the order.
    (2) As part of your appeal, you may request an informal hearing. 
Your appeal must include specific facts showing there is a genuine and 
substantial issue of fact that requires a hearing.
    (3) If we grant your request for an informal hearing, we will follow 
the regulatory hearing requirements at in part 16, except that:
    (i) The written order will serve as notice of opportunity for that 
hearing, for purposes of Sec. 16.22(a) of this chapter;
    (ii) The presiding officer will issue a decision rather than a 
report and a recommended decision. The presiding officer's decision 
constitutes final agency action.

[68 FR 62368, Nov. 4, 2003]