Sections 738(d)(2)(B) and 738(e)(2)(B) of the FD&C Act require an applicant to pay the standard fees for its submissions unless it demonstrates it is a small business by submitting a copy of its most recent Federal (U.S.) income tax returns (and returns of all affiliates). A consequence of this requirement is that you cannot qualify as a small business under MDUFA if you have not submitted a Federal (U.S.) income tax return. FDA cannot accept a foreign tax return or state tax return in place of a Federal (U.S.) income tax return.
