Although the law does not prohibit a foreign business from submitting a Federal (U.S.)
income tax return, filing a Federal (U.S.) income tax return may have significant tax and
other legal consequences beyond simply making you eligible as a small business under
MDUFA. FDA cannot provide advice regarding whether you should or should not file a
Federal (U.S.) income tax return. If you are in doubt as to whether it is advisable for you to
file a Federal (U.S.) income tax return, you should consider consulting with qualified legal
and tax professionals. Additional information on Federal (U.S.) income taxation is available
from the United States Internal Revenue Service (www.irs.gov).
