under section 506A, any additional infor-
mation the Secretary may require (which 
may include data on bioequivalence if such 
data are not required under section 506A), 
and, with respect to the permitted country 
that approved the qualifying drug for com-
mercial distribution, or with respect to 
which such approval is sought, include the 
following: 
‘‘(I) The date on which the quali-
fying drug with such difference was, 
or will be, introduced for commercial 
distribution in the permitted country. 
‘‘(II) Information demonstrating 
that the person submitting the notice 
has also notified the government of 
the permitted country in writing that 
the person is submitting to the Sec-
retary a notice under clause (i)(I), 
which notice describes the difference 
in the qualifying drug from a condi-
tion established in the approved appli-
cation for the U.S. label drug. 
‘‘(III) The information that the 
person submitted or will submit to the
government of the permitted country 
for purposes of obtaining approval for 
commercial distribution of the drug in 
the country which, if in a language 
other than English, shall be accom-
panied by an English translation 
verified to be complete and accurate, 
with the name, address, and a brief 
statement of the qualifications of the 
person that made the translation. 
‘‘(iii) CERTIFICATIONS.—The chief ex-
ecutive officer and the chief medical officer 
of the manufacturer involved shall each 
certify in the notice under clause (i) that— 
‘‘(I) the information provided in 
the notice is complete and true; and 
‘‘(II) a copy of the notice has 
been provided to the Federal Trade 
Commission and to the State attor-
neys general. 
‘‘(iv) FEE.—If a notice submitted 
under clause (i) includes a difference that 
would, under section 506A, require the 
submission of a supplemental application if 
made as a change to the U.S. label drug,
the person that submits the notice shall 
pay to the Secretary a fee in the same 
amount as would apply if the person were 
paying 
a 
fee 
pursuant 
to 
section 
736(a)(1)(A)(ii). Subject to appropriations 
Acts, fees collected by the Secretary under 
the preceding sentence are available only to 
the Secretary and are for the sole purpose 
of paying the costs of reviewing notices 
submitted under clause (i). 
‘‘(v) TIMING OF SUBMISSION OF NO-
TICES.— 
‘‘(I) 
PRIOR
APPROVAL
NO-
TICES.—A notice under clause (i) to 
which subparagraph (C) applies shall 
be submitted to the Secretary not 
later than 120 days before the quali-
fying drug with the difference is intro-
duced for commercial distribution in a 
permitted country, unless the country 
requires that distribution of the quali-
fying drug with the difference begin 
less than 120 days after the country 
requires the difference.
‘‘(II) 
OTHER
APPROVAL
NO-
TICES.—A notice under clause (i) to 
which subparagraph (D) applies shall 
be submitted to the Secretary not 
later than the day on which the quali-
fying drug with the difference is intro-
duced for commercial distribution in a 
permitted country. 
‘‘(III) OTHER
NOTICES.—A no-
tice under clause (i) to which subpara-
graph (E) applies shall be submitted 
to the Secretary on the date that the 
qualifying drug is first introduced for 
commercial distribution in a permitted 
country and annually thereafter. 
‘‘(vi) REVIEW BY SECRETARY.— 
‘‘(I) IN GENERAL.—In this para-
graph, the difference in a qualifying 
drug that is submitted in a notice 
under clause (i) from the U.S. label 
drug shall be treated by the Secretary 
as if it were a manufacturing change 
to the U.S. label drug under section 
506A.
‘‘(II) STANDARD
OF
REVIEW.—
Except as provided in subclause (III), 
the Secretary shall review and approve 
or disapprove the difference in a no-
tice submitted under clause (i), if re-
quired under section 506A, using the 
safe and effective standard for ap-
proving or disapproving a manufac-
turing change under section 506A. 
‘‘(III) BIOEQUIVALENCE.—If the 
Secretary would approve the dif-
ference in a notice submitted under 
clause (i) using the safe and effective 
standard under section 506A and if 
the Secretary determines that the 
qualifying drug is not bioequivalent to 
the U.S. label drug, the Secretary 
may— 
‘‘(aa) include in the labeling 
provided under paragraph (3) a 
prominent 
advisory 
that 
the 
qualifying drug is safe and effec-
tive but is not bioequivalent to 
the U.S. label drug if the Sec-
retary determines that such an
advisory is necessary for health 
care practitioners and patients to 
use the qualifying drug safely 
and effectively; or 
‘‘(bb) decline to approve the 
difference if the Secretary deter-
mines that the availability of 
both the qualifying drug and the 
U.S. label drug would pose a 
threat to the public health. 
‘‘(IV) REVIEW
BY
THE
SEC-
RETARY.—The Secretary shall review 
and approve or disapprove the dif-
ference in a notice submitted under 
clause (i), if required under section 
506A, not later than 120 days after 
the date on which the notice is sub-
mitted. 
‘‘(V) ESTABLISHMENT
INSPEC-
TION.—If review of such difference 
would require an inspection of the es-
tablishment in which the qualifying 
drug is manufactured—
‘‘(aa) such inspection by the 
Secretary shall be authorized; 
and 
‘‘(bb) the Secretary may rely 
on a satisfactory report of a good 
manufacturing practice inspec-
tion of the establishment from a 
permitted country whose regu-
latory system the Secretary rec-
ognizes as equivalent under a 
mutual recognition agreement, as 
provided under section 510(i)(3), 
section 803, or part 26 of title 
21, Code of Federal Regulations 
(or any corresponding successor 
rule or regulation). 
‘‘(vii) PUBLICATION OF INFORMATION 
ON NOTICES.— 
‘‘(I) IN GENERAL.—Through the 
Internet website of the Food and 
Drug Administration and a toll-free 
telephone number, the Secretary shall 
readily make available to the public a 
list of notices submitted under clause 
(i).
‘‘(II) CONTENTS.—The list under 
subclause (I) shall include the date on 
which a notice is submitted and 
whether— 
‘‘(aa) a notice is under re-
view; 
‘‘(bb) the Secretary has or-
dered that importation of the 
qualifying drug from a permitted 
country cease; or 
‘‘(cc) the importation of the 
drug is permitted under sub-
section (a). 
‘‘(III) UPDATE.—The Secretary 
shall promptly update the Internet 
website with any changes to the list. 
‘‘(C) NOTICE; DRUG DIFFERENCE REQUIR-
ING PRIOR APPROVAL.—In the case of a notice 
under subparagraph (B)(i) that includes a dif-
ference that would, under section 506A(c) or 
(d)(3)(B)(i), require the approval of a supple-
mental application before the difference could 
be made to the U.S. label drug the following 
shall occur: