21 CFR §207.69

1. (a)Official contact. Registrants subject to the registration requirements of this part must designate an official contact for each establishment. The official contact is responsible for:
   1. (1)Ensuring the accuracy of registration and listing information; and
   2. (2)Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications.
2. (b)United States agent. Registrants of foreign establishments subject to this part must designate a single United States agent. The United States agent must reside or maintain a place of business in the United States and may not be a mailbox, answering machine or service, or other place where a person acting as the United States agent is not physically present. The United States agent is responsible for:
   1. (1)Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications;
   2. (2)Responding to questions concerning those drugs that are imported or offered for import to the United States;
   3. (3)Assisting FDA in scheduling inspections; and
   4. (4)If FDA is unable to contact a foreign registrant directly or expeditiously, FDA may provide the information and/or documents to the United States agent. FDA's providing information and/or documents to the United States agent is equivalent to providing the same information and/or documents to the foreign registrant.