The foreign facility is responsible for making arrangements with the person designated as its U.S.
agent or its designated emergency contact. A U.S. agent may be an individual, partnership,
corporation, or association. Because the role of the U.S. agent is to act as a communications link
between the facility and FDA, FDA intends to communicate through the U.S. agent in both
routine registration matters and emergency situations. This means that the U.S. agent must be
accessible to FDA 24 hours a day, 7 days a week, unless the foreign facility opts to designate a
different person other than the facility’s U.S. agent as the facility’s emergency contact by
providing the information specified in 21 CFR 1.232(c)(2) in the facility’s registration. In terms
of ensuring such accessibility, FDA suggests that the foreign facility may wish to specify the
terms of availability in any written agreement it has with its U.S. agent or emergency contact.
