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shall, if warranted, make appropriate changes 
to the methodology, and the changes shall be ef-
fective for each of the fiscal years 2010 through 
2012. The Secretary shall not make any adjust-
ment for changes in review activities for any 
fiscal year after 2009 unless such study has 
been completed.’’. 
(3) RENT AND RENT-RELATED COST ADJUST-
MENT.—Section 736(c) (21 U.S.C. 379h(c)) is 
amended— 
(A) by redesignating paragraphs (3), (4), 
and (5) as paragraphs (4), (5), and (6), respec-
tively; and 
(B) by inserting after paragraph (2) the 
following: 
‘‘(3) RENT AND RENT-RELATED COST ADJUST-
MENT.—For fiscal year 2010 and each subsequent 
fiscal year, the Secretary shall, before making ad-
justments under paragraphs (1) and (2), decrease 
the fee revenue amount established in subsection (b) 
if actual costs paid for rent and rent-related ex-
penses for the preceding fiscal year are less than es-
timates made for such year in fiscal year 2006. Any 
reduction made under this paragraph shall not ex-
ceed the amount by which such costs fall below the 
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estimates made in fiscal year 2006 for such fiscal 
year, and shall not exceed $11,721,000 for any fiscal 
year.’’. 
(4) FINAL YEAR ADJUSTMENT.—Section 736(c) 
(21 U.S.C. 379h(c)) is amended— 
(A) in paragraph (4) (as redesignated by 
paragraph (3)(A))— 
(i) by striking ‘‘2007’’ each place it 
appears and inserting ‘‘2012’’; 
(ii) by striking ‘‘paragraphs (1) and 
(2)’’ and inserting ‘‘paragraphs (1), (2), 
and (3)’’; and 
(iii) by striking ‘‘2008’’ and inserting 
‘‘2013’’; and 
(B) in paragraph (5) (as so redesignated), 
by striking ‘‘2002’’ and inserting ‘‘2007’’. 
(d) FEE WAIVER OR REDUCTION.—Section 736(d) 
(21 U.S.C. 379h(d)) is amended— 
(1) in paragraph (1), in the matter preceding 
subparagraph (A)— 
(A) by inserting after ‘‘The Secretary shall 
grant’’ the following: ‘‘to a person who is 
named as the applicant in a human drug appli-
cation’’; and 
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(B) by inserting ‘‘to that person’’ after 
‘‘one or more fees assessed’’; 
(2) by redesignating paragraphs (2) and (3) as 
paragraphs (3) and (4), respectively; 
(3) by inserting after paragraph (1) the fol-
lowing: 
‘‘(2) CONSIDERATIONS.—In determining wheth-
er to grant a waiver or reduction of a fee under 
paragraph (1), the Secretary shall consider only the 
circumstances and assets of the applicant involved 
and any affiliate of the applicant.’’; and 
(4) in paragraph (4) (as redesignated by para-
graph (2)), in subparagraph (A), by inserting before 
the period the following: ‘‘, and that does not have 
a drug product that has been approved under a 
human drug application and introduced or delivered 
for introduction into interstate commerce’’. 
(e) CREDITING AND AVAILABILITY OF FEES.— 
(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is amend-
ed to read as follows: 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of the fiscal years 2008 through 2012, 
there is authorized to be appropriated for fees under 
this section an amount equal to the total revenue 
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amount determined under subsection (b) for the fis-
cal year, as adjusted or otherwise affected under 
subsection (c) and paragraph (4) of this sub-
section.’’. 
(2) OFFSET.—Section 736(g)(4) (21 U.S.C. 
379h(g)(4)) is amended to read as follows: 
‘‘(4) OFFSET.—If the sum of the cumulative 
amount of fees collected under this section for the 
fiscal years 2008 through 2010 and the amount of 
fees estimated to be collected under this section for 
fiscal year 2011 exceeds the cumulative amount ap-
propriated under paragraph (3) for the fiscal years 
2008 through 2011, the excess shall be credited to 
the appropriation account of the Food and Drug Ad-
ministration as provided in paragraph (1), and shall 
be subtracted from the amount of fees that would 
otherwise be authorized to be collected under this 
section pursuant to appropriation Acts for fiscal 
year 2012.’’. 
(f) EXEMPTION FOR ORPHAN DRUGS.—Section 736 
(21 U.S.C. 379h) is further amended by adding at the 
end the following: 
‘‘(k) ORPHAN DRUGS.—A drug designated under sec-
tion 526 for a rare disease or condition and approved 
under section 505 or under section 351 of the Public 
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Health Service Act shall be exempt from product and facil-
ity fees under this section, provided that the drug meets 
all of the following: 
‘‘(1) The drug had United States sales in the 
previous year of less than $25,000,000 for the active 
moiety, for all indications, dosage forms, and 
strengths for which the drug is approved and for 
any off-label uses. 
‘‘(2) The drug meets the public health require-
ments contained in this Act as such requirements 
are applied to requests for waivers for product and 
facility fees. 
‘‘(3) The drug is owned or licensed and mar-
keted 
by 
a 
company 
that 
had 
less 
than 
$100,000,000 in gross worldwide revenue during the 
previous year.’’. 
(g) CONFORMING AMENDMENT.—Section 736(a) (21 
U.S.C. 379h(a)) is amended in paragraphs (1)(A)(i), 
(1)(A)(ii), (2)(A), and (3)(A) by striking ‘‘(c)(4)’’ each 
place such term appears and inserting ‘‘(c)(5)’’. 
SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRE-
SCRIPTION-DRUG TELEVISION ADVERTISING. 
Part 2 of subchapter C of chapter VII (21 U.S.C. 
379g et seq.) is amended by adding after section 736 the 
following: 
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‘‘SEC. 736A. FEES RELATING TO ADVISORY REVIEW OF PRE-
SCRIPTION-DRUG TELEVISION ADVERTISING. 
‘‘(a) TYPES OF DIRECT-TO-CONSUMER TELEVISION 
ADVERTISEMENT REVIEW FEES.—Beginning in fiscal 
year 2008, the Secretary shall assess and collect fees in 
accordance with this section as follows: 
‘‘(1) ADVISORY REVIEW FEE.— 
‘‘(A) IN GENERAL.—With respect to a pro-
posed direct-to-consumer television advertise-
ment (referred to in this section as a ‘DTC ad-
vertisement’), each person that on or after Oc-
tober 1, 2007, submits such an advertisement 
for advisory review by the Secretary prior to its 
initial public broadcast (referred to in this sec-
tion as ‘prebroadcast advisory review’) shall, ex-
cept as provided in subparagraph (B), be sub-
ject to a fee established under subsection (c)(3). 
‘‘(B) EXCEPTION FOR REQUIRED SUBMIS-
SIONS.—A DTC advertisement that is required 
under section 502(n) to be submitted to the 
Secretary prior to initial public broadcast is not 
subject to a fee under subparagraph (A) unless 
the sponsor designates the submission as a sub-
mission for prebroadcast advisory review. 
‘‘(C) NOTICE TO SECRETARY OF NUMBER 
OF ADVERTISEMENTS.—Not later than June 1 
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of each fiscal year, the Secretary shall publish 
a notice in the Federal Register requesting any 
person to notify the Secretary within 30 days of 
the number of DTC advertisements the person 
intends to submit for prebroadcast advisory re-
view in the next fiscal year. 
‘‘(D) PAYMENT.— 
‘‘(i) IN GENERAL.—The fee required 
by subparagraph (A) (referred to in this 
section as ‘an advisory review fee’) shall be 
due not later than October 1 of the fiscal 
year in which the DTC advertisement in-
volved is intended be submitted for 
prebroadcast advisory review, subject to 
subparagraph (F)(i). 
‘‘(ii) EFFECT OF SUBMISSION.—Noti-
fication of the Secretary under subpara-
graph (C) of the number of DTC adver-
tisements a person intends to submit for 
prebroadcast advisory review is a legally 
binding commitment by that person to pay 
the annual advisory review fee for that 
number of submissions on or before Octo-
ber 1 of the fiscal year in which the adver-
tisement is intended to be submitted. 
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‘‘(iii) NOTICE REGARDING CARRYOVER 
SUBMISSIONS.—In making a notification 
under subparagraph (C), the person in-
volved shall in addition notify the Sec-
retary if under subparagraph (F)(i) the 
person intends to submit a DTC advertise-
ment for which the advisory review fee has 
already been paid. If the person does not 
so notify the Secretary, each DTC adver-
tisement submitted by the person for 
prebroadcast advisory review in the fiscal 
year involved shall be subject to the advi-
sory review fee. 
‘‘(E) MODIFICATION OF ADVISORY REVIEW 
FEE.— 
‘‘(i) LATE PAYMENT.—If a person has 
submitted a notification under subpara-
graph (C) with respect to a fiscal year and 
has not paid all advisory review fees due 
under subparagraph (D) on or before No-
vember 1 of such fiscal year, the fees are 
regarded as late and a revised due date 
and an increase in the amount of fees ap-
plies in accordance with this clause, not-
withstanding any other provision of this 
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section. For such person, the advisory re-
view fee for each DTC advertisement sub-
mitted in such fiscal year for prebroadcast 
advisory review shall be due and payable 
20 days before the advertisement is sub-
mitted to the Secretary, and each such fee 
shall be revised to be equal to 150 percent 
of the fee that otherwise would have ap-
plied pursuant to subsection (c)(3). 
‘‘(ii) EXCEEDING
IDENTIFIED
NUM-
BER OF SUBMISSIONS.—If a person sub-
mits 
a 
number 
of 
DTC 
ads 
for 
prebroadcast advisory review in a fiscal 
year that exceeds the number identified by 
the person under subparagraph (C), a re-
vised due date and an increase in the 
amount of fees applies under this clause 
for each submission in excess of such num-
ber, notwithstanding any other provision of 
this section. For each such DTC ad, the 
advisory review fee shall be due and pay-
able 20 days before the advertisement is 
submitted to the Secretary, and the fee 
shall be revised to be equal to 150 percent 
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of the fee that otherwise would have ap-
plied pursuant to subsection (c)(3). 
‘‘(F) LIMITS.— 
‘‘(i) SUBMISSIONS.—For each advi-
sory review fee paid by a person for a fis-
cal year, the person is entitled to accept-
ance for advisory review by the Secretary 
of one DTC advertisement and acceptance 
of one resubmission for advisory review of 
the same advertisement. The advertisement 
shall be submitted for review in the fiscal 
year for which the fee was assessed, except 
that a person may carry over not more 
than one paid advisory review submission 
to the next fiscal year. Resubmissions may 
be submitted without regard to the fiscal 
year of the initial advisory review submis-
sion. 
‘‘(ii) NO REFUNDS.—Except as pro-
vided by subsection (f), fees paid under 
subparagraph (A) shall not be refunded. 
‘‘(iii) NO WAIVERS, EXEMPTIONS, OR 
REDUCTIONS.—The Secretary shall not 
grant a waiver, exemption, or reduction of 
any fees due or payable under this section. 
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‘‘(iv) RIGHT
TO
ADVISORY
REVIEW 
NOT TRANSFERABLE.—The right to an ad-
visory review under this paragraph is not 
transferable, except to a successor in inter-
est. 
‘‘(2) OPERATING RESERVE FEE.— 
‘‘(A) IN GENERAL.—Each person that on 
or after October 1, 2007, is assessed an advi-
sory review fee under paragraph (1) shall be 
subject to fee established under subsection 
(d)(2) referred to in this section as an ‘oper-
ating reserve fee’ for the first fiscal year in 
which an advisory review fee is assessed to such 
person. The person is not subject to an oper-
ating reserve fee for any other fiscal year. 
‘‘(B) PAYMENT.—Except as provided in 
subparagraph (C), the operating reserve fee 
shall be due no later than October 1 of the first 
fiscal year in which the person is required to 
pay an advisory review fee under paragraph (1). 
‘‘(C) LATE NOTICE OF SUBMISSION.—If, in 
the first fiscal year of a person’s participation 
in the program under this section, that person 
submits 
any 
DTC 
advertisements 
for 
prebroadcast advisory review that are in excess 
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of the number identified by that person in re-
sponse to the Federal Register notice described 
in subsection (a)(1)(C), that person shall pay 
an operating reserve fee for each of those advi-
sory reviews equal to the advisory review fee for 
each submission established under paragraph 
(1)(D)(ii). Fees required by this subparagraph 
shall be in addition to any fees required by sub-
paragraph (A). Fees under this subparagraph 
shall be due 20 days before any DTC advertise-
ment is submitted by such person to the Sec-
retary for prebroadcast advisory review. 
‘‘(b) ADVISORY REVIEW FEE REVENUE AMOUNTS.— 
Fees under subsection (a)(1) shall be established to gen-
erate revenue amounts of $6,250,000 for each of fiscal 
years 2008 through 2012, as adjusted pursuant to sub-
sections (c) and (g)(4). 
‘‘(c) ADJUSTMENTS.— 
‘‘(1) 
INFLATION
ADJUSTMENT.—Beginning 
with fiscal year 2009, the revenues established in 
subsection (b) shall be adjusted by the Secretary by 
notice, published in the Federal Register, for a fiscal 
year to reflect the greater of— 
‘‘(A) the total percentage change that oc-
curred in the Consumer Price Index for all 
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