FDA is concerned that acting as a U.S. agent may conflict with the duties of foreign government
representatives (see Comment 90 in the preamble to the Interim Final Rule; 68 FR 58894 at
58916). Whether it is proper for a foreign government representative to act as a U.S. agent is a
fact-specific inquiry, depending on the title and status of the foreign government representative
and the functions that the representative assumes as a U.S. agent. FDA will consider such
situations on a case-by-case basis in consultation with the U.S. State Department.