This message was posted by a user wishing to remain anonymous
I do not understand why a US based Company would also identify themselves as a US Agent.
Per 21 CFR 207.69(b):
(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) Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications;
(2) Responding to questions concerning those drugs that are imported or offered for import to the United States;
(3) Assisting FDA in scheduling inspections; and
(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.
Per 21 CFR 316.22:
Every foreign sponsor that seeks orphan-drug designation shall name a permanent resident of the United States as the sponsor's agent upon whom service of all processes, notices, orders, decisions, requirements, and other communications may be made on behalf of the sponsor. Notifications of changes in such agents or changes of address of agents should preferably be provided in advance, but not later than 60 days after the effective date of such changes. The permanent-resident agent may be an individual, firm, or domestic corporation and may represent any number of sponsors. The name of the permanent-resident agent, address, telephone number, and email address shall be provided to: Office of Orphan Products Development, Food and Drug Administration, Bldg. 32, rm. 5271, 10903 New Hampshire Ave., Silver Spring, MD 20993.
For Form 356h, the instructions for the US Agent field states: Enter the name, street address, applicant DUNS number, US Agent DUNS and telephone number of the person and legal entity authorized to represent a non-U.S. applicant in Field 6.
There are other regulatory citations regarding a US agent but all state that a US agent is required for a foreign sponsor or foreign establishment. These regulations do not say that a US company must designate themselves as a US agent.
Original Message:
Sent: 19-Feb-2021 11:57
From: Ruth Collins
Subject: Adding a facility
We are about to commission an additional building across a parking lot from the existing facility (think business park). Who do I notify and how? Tell the district and report it in annual reports of the affected product? This phase doesn't involve any type of site transfer filing. In another phase, Regulatory will move into the building, but the mail will still go to the main building. Is the address for US Agents a physical address or mailing address?
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Ruth Collins RAC
Manager Regulatory Affairs
Euless TX
United States
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