total price of drugs imported under subsection 
(a) of such section 804 into the United States 
by registered importers during— 
(i) 
fiscal 
year 
2006 
to 
be 
$1,000,000,000; and 
(ii) 
fiscal 
year 
2007 
to 
be 
$10,000,000,000. 
(C) FISCAL YEAR 2007 ADJUSTMENT.—
(i) REPORTS.—Not later than Feb-
ruary 20, 2007, registered importers shall 
report to the Secretary the total price and 
the total volume of drugs imported to the 
United States by the importer during the 
4-month period from October 1, 2006, 
through January 31, 2007. 
(ii) 
REESTIMATE.—Notwithstanding 
subsection (e)(3)(C)(ii) of such section 804 
or subparagraph (B), the Secretary shall 
reestimate the total price of qualifying 
drugs imported under subsection (a) of 
such section 804 into the United States by 
registered importers during fiscal year 
2007. Such reestimate shall be equal to—
(I) the total price of qualifying 
drugs imported by each importer as
100
reported under clause (i); multiplied 
by 
(II) 3. 
(iii) ADJUSTMENT.—The Secretary 
shall adjust the fee due on April 1, 2007, 
from each importer so that the aggregate 
total of fees collected under subsection 
(e)(2) for fiscal year 2007 does not exceed 
the total price of qualifying drugs imported 
under subsection (a) of such section 804 
into the United States by registered im-
porters during fiscal year 2007 as reesti-
mated under clause (ii). 
(D) ANNUAL REPORT.— 
(i) FOOD
AND
DRUG
ADMINISTRA-
TION.—Beginning with fiscal year 2006, 
not later than 180 days after the end of 
each fiscal year during which fees are col-
lected 
under 
subsection 
(e), 
(f), 
or 
(g)(2)(B)(iv) of such section 804, the Sec-
retary shall prepare and submit to the 
House of Representatives and the Senate a 
report on the implementation of the au-
thority for such fees during such fiscal 
year and the use, by the Food and Drug
101
Administration, of the fees collected for the 
fiscal year for which the report is made 
and credited to the Food and Drug Admin-
istration. 
(ii) CUSTOMS
AND
BORDER
CON-
TROL.—Beginning with fiscal year 2006, 
not later than 180 days after the end of 
each fiscal year during which fees are col-
lected under subsection (e) or (f) of such 
section 804, the Secretary of Homeland 
Security, in consultation with the Sec-
retary of the Treasury, shall prepare and 
submit to the House of Representatives 
and the Senate a report on the use, by the 
Bureau of Customs and Border Protection, 
of the fees, if any, transferred by the Sec-
retary to the Bureau of Customs and Bor-
der Protection for the fiscal year for which 
the report is made. 
(f) IMPLEMENTATION OF SECTION 804.— 
(1) INTERIM RULE.—The Secretary may pro-
mulgate an interim rule for implementing section 
804 of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (a) of this section.
102
(2) NO NOTICE OF PROPOSED RULEMAKING.—
The interim rule described under paragraph (1) may 
be developed and promulgated by the Secretary with-
out providing general notice of proposed rulemaking. 
(3) FINAL RULE.—Not later than 1 year after 
the date on which the Secretary promulgates an in-
terim rule under paragraph (1), the Secretary shall, 
in accordance with procedures under section 553 of 
title 5, United States Code, promulgate a final rule 
for implementing such section 804, which may incor-
porate by reference provisions of the interim rule 
provided for under paragraph (1), to the extent that 
such provisions are not modified. 
(g) CONSUMER EDUCATION.—The Secretary shall 
carry out activities that educate consumers— 
(1) with regard to the availability of qualifying 
drugs for import for personal use from an exporter 
registered with and approved by the Food and Drug 
Administration under section 804 of the Federal 
Food, Drug, and Cosmetic Act, as added by this sec-
tion, including information on how to verify whether 
an exporter is registered and approved by use of the 
Internet website of the Food and Drug Administra-
tion and the toll-free telephone number required by 
this Act;
103
(2) that drugs that consumers attempt to im-
port from an exporter that is not registered with and 
approved by the Food and Drug Administration can 
be seized by the United States Customs Service and 
destroyed, and that such drugs may be counterfeit, 
unapproved, unsafe, or ineffective; and 
(3) with regard to the availability at domestic 
retail pharmacies of qualifying drugs imported under 
such section 804 by domestic wholesalers and phar-
macies registered with and approved by the Food 
and Drug Administration. 
(h) EFFECT ON ADMINISTRATION PRACTICES.—Not-
withstanding any provision of this Act (and the amend-
ments made by this Act), nothing in this Act (or the 
amendments made by this Act) shall be construed to 
change, limit, or restrict the practices of the Food and 
Drug Administration or the Bureau of Customs and Bor-
der Protection in effect on January 1, 2004, with respect 
to the importation of prescription drugs into the United 
States by an individual, on the person of such individual, 
for personal use. 
SEC. 5. DISPOSITION OF CERTAIN DRUGS DENIED ADMIS-
SION INTO UNITED STATES. 
(a) IN GENERAL.—Chapter VIII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.),