‘‘(i) Promptly after the notice is sub-
mitted, the Secretary shall notify reg-
istered exporters, registered importers, the 
Federal Trade Commission, and the State 
attorneys general that the notice has been 
submitted with respect to the qualifying 
drug involved. 
‘‘(ii) If the Secretary has not made a 
determination whether such a supple-
mental application regarding the U.S. label 
drug would be approved or disapproved by 
the date on which the qualifying drug in-
volved is to be introduced for commercial 
distribution in a permitted country, the 
Secretary shall— 
‘‘(I) order that the importation of 
the qualifying drug involved from the 
permitted country not begin until the 
Secretary completes review of the no-
tice; and 
‘‘(II) promptly notify registered 
exporters, registered importers, the 
Federal Trade Commission, and the 
State attorneys general of the order.
‘‘(iii) If the Secretary determines that 
such a supplemental application regarding 
the U.S. label drug would not be approved, 
the Secretary shall— 
‘‘(I) order that the importation of 
the qualifying drug involved from the 
permitted country cease, or provide 
that an order under clause (ii), if any, 
remains in effect; 
‘‘(II) notify the permitted coun-
try that approved the qualifying drug 
for commercial distribution of the de-
termination; and 
‘‘(III) promptly notify registered 
exporters, registered importers, the 
Federal Trade Commission, and the 
State attorneys general of the deter-
mination. 
‘‘(iv) If the Secretary determines that 
such a supplemental application regarding 
the U.S. label drug would be approved, the 
Secretary shall— 
‘‘(I) vacate the order under 
clause (ii), if any;
‘‘(II) consider the difference to 
be a variation provided for in the ap-
proved application for the U.S. label 
drug; 
‘‘(III) permit importation of the 
qualifying drug under subsection (a); 
and 
‘‘(IV) promptly notify registered 
exporters, registered importers, the 
Federal Trade Commission, and the 
State attorneys general of the deter-
mination. 
‘‘(D) NOTICE; DRUG DIFFERENCE NOT RE-
QUIRING PRIOR APPROVAL.—In the case of a 
notice under subparagraph (B)(i) that includes 
a 
difference 
that 
would, 
under 
section 
506A(d)(3)(B)(ii), not require the approval of a 
supplemental application before the difference 
could be made to the U.S. label drug the fol-
lowing shall occur: 
‘‘(i) During the period in which the 
notice is being reviewed by the Secretary, 
the authority under this subsection to im-
port the qualifying drug involved continues 
in effect.
‘‘(ii) If the Secretary determines that 
such a supplemental application regarding 
the U.S. label drug would not be approved, 
the Secretary shall— 
‘‘(I) order that the importation of 
the qualifying drug involved from the 
permitted country cease; 
‘‘(II) notify the permitted coun-
try that approved the qualifying drug 
for commercial distribution of the de-
termination; and 
‘‘(III) promptly notify registered 
exporters, registered importers, the 
Federal Trade Commission, and the 
State attorneys general of the deter-
mination. 
‘‘(iii) If the Secretary determines that 
such a supplemental application regarding 
the U.S. label drug would be approved, the 
difference shall be considered to be a vari-
ation provided for in the approved applica-
tion for the U.S. label drug. 
‘‘(E) NOTICE; DRUG DIFFERENCE NOT RE-
QUIRING APPROVAL; NO DIFFERENCE.—In the 
case of a notice under subparagraph (B)(i) that