gate total of fees to be collected under para-
graph (2) for exporters for that fiscal year that 
is sufficient, and not more than necessary, to 
pay the costs for that fiscal year of admin-
istering this section with respect to registered 
exporters, including the costs associated with— 
‘‘(i) inspecting the facilities of reg-
istered exporters, and of other entities in 
the chain of custody of a qualifying drug 
as necessary, under subsection (d)(3); 
‘‘(ii) developing, implementing, and 
operating under such subsection a system 
to screen marks on shipments of qualifying 
drugs under subsection (a) that indicate 
compliance with all registration conditions, 
when such shipments are offered for im-
port into the United States; and 
‘‘(iii) screening such markings, and 
inspecting such shipments as necessary, 
when offered for import into the United 
States to determine if such a shipment 
should be refused admission under sub-
section (g)(5). 
‘‘(B) LIMITATION.—Subject to subpara-
graph (C), the aggregate total of fees collected
under paragraph (2) for a fiscal year shall not 
exceed 1 percent of the total price of qualifying 
drugs imported during that fiscal year into the 
United States by registered exporters under 
subsection (a). 
‘‘(C) TOTAL PRICE OF DRUGS.— 
‘‘(i) ESTIMATE.—For the purposes of 
complying with the limitation described in 
subparagraph (B) when establishing under 
subparagraph (A) the aggregate total of 
fees to be collected under paragraph (2) 
for a fiscal year, the Secretary shall esti-
mate the total price of qualifying drugs im-
ported into the United States by registered 
exporters during that fiscal year by adding 
the total price of qualifying drugs exported 
by each registered exporter during the 6-
month period from January 1 through 
June 30 of the previous fiscal year, as re-
ported to the Secretary by each registered 
exporter under subsection (b)(1)(I)(iv). 
‘‘(ii) CALCULATION.—Not later than 
March 1 of the fiscal year that follows the 
fiscal year for which the estimate under 
clause (i) is made, the Secretary shall cal-
culate the total price of qualifying drugs 
imported into the United States by reg-
istered exporters during that fiscal year by 
adding the total price of qualifying drugs 
exported by each registered exporter dur-
ing that fiscal year, as reported to the Sec-
retary by each registered exporter under 
subsection (b)(1)(I)(iv). 
‘‘(iii) 
ADJUSTMENT.—If 
the 
total 
price of qualifying drugs imported into the 
United States by registered exporters dur-
ing a fiscal year as calculated under clause 
(ii) is less than the aggregate total of fees 
collected under paragraph (2) for that fis-
cal year, the Secretary shall provide for a 
pro-rata reduction in the fee due from each 
registered exporter on April 1 of the subse-
quent fiscal year so that the limitation de-
scribed in subparagraph (B) is observed. 
‘‘(D) INDIVIDUAL EXPORTER FEE.—Sub-
ject to the limitation described in subparagraph 
(B), the fee under paragraph (2) to be paid on 
October 1 and April 1 by an exporter shall be 
an amount that is proportional to a reasonable 
estimate by the Secretary of the semiannual
share of the exporter of the volume of quali-
fying drugs exported by exporters under sub-
section (a). 
‘‘(4) USE OF FEES.— 
‘‘(A) IN GENERAL.—Subject to appropria-
tions Acts, fees collected by the Secretary under 
paragraphs (1) and (2) shall be credited to the 
appropriation account for salaries and expenses 
of the Food and Drug Administration until ex-
pended (without fiscal year limitation), and the 
Secretary may, in consultation with the Sec-
retary of Homeland Security and the Secretary 
of the Treasury, transfer some proportion of 
such fees to the appropriation account for sala-
ries and expenses of the Bureau of Customs 
and Border Protection until expended (without 
fiscal year limitation). 
‘‘(B) SOLE
PURPOSE.—Fees collected by 
the Secretary under paragraphs (1) and (2) are 
only available to the Secretary and, if trans-
ferred, to the Secretary of Homeland Security, 
and are for the sole purpose of paying the costs 
referred to in paragraph (3)(A). 
‘‘(5) COLLECTION OF FEES.—In any case where 
the Secretary does not receive payment of a fee as-
sessed under paragraph (1) or (2) within 30 days 
after it is due, such fee shall be treated as a claim 
of the United States Government subject to sub-
chapter II of chapter 37 of title 31, United States 
Code. 
‘‘(g) COMPLIANCE WITH SECTION 801(a).— 
‘‘(1) IN GENERAL.—A registration condition is 
that each qualifying drug exported under subsection 
(a) by the registered exporter involved or imported 
under subsection (a) by the registered importer in-
volved is in compliance with the standards referred 
to in section 801(a) regarding admission of the drug 
into the United States, subject to paragraphs (2), 
(3), and (4). 
‘‘(2) SECTION 505; APPROVAL STATUS.— 
‘‘(A) IN GENERAL.—A qualifying drug that 
is imported or offered for import under sub-
section (a) shall comply with the conditions es-
tablished in the approved application under sec-
tion 505(b) for the U.S. label drug as described 
under this subsection. 
‘‘(B) NOTICE
BY
MANUFACTURER; GEN-
ERAL PROVISIONS.— 
‘‘(i) IN GENERAL.—The person that 
manufactures a qualifying drug that is, or