‘‘(C) the average annual change in the 
cost, per full-time equivalent position of the 
Food and Drug Administration, of all personnel 
compensation and benefits paid with respect to 
such positions for the first 5 fiscal years of the 
previous 6 fiscal years. 
The adjustment made each fiscal year by this sub-
section will be added on a compounded basis to the 
sum of all adjustments made each fiscal year after 
fiscal year 2008 under this subsection. 
‘‘(2) 
WORKLOAD
ADJUSTMENT.—Beginning 
with fiscal year 2009, after the fee revenues estab-
lished in subsection (b) are adjusted for a fiscal year 
for inflation in accordance with paragraph (1), the 
fee revenues shall be adjusted further for such fiscal 
year to reflect changes in the workload of the Sec-
retary with respect to the submission of DTC adver-
tisements for advisory review prior to initial broad-
cast. With respect to such adjustment: 
‘‘(A) The adjustment shall be determined 
by the Secretary based upon the number of 
DTC advertisements identified pursuant to sub-
section (a)(1)(C) for the upcoming fiscal year, 
excluding allowable previously paid carry over 
submissions. The adjustment shall be deter-
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mined by multiplying the number of such adver-
tisements projected for that fiscal year that ex-
ceeds 150 by $27,600 (adjusted each year be-
ginning with fiscal year 2009 for inflation in 
accordance with paragraph (1)). The Secretary 
shall publish in the Federal Register the fee 
revenues and fees resulting from the adjust-
ment and the supporting methodologies. 
‘‘(B) Under no circumstances shall the ad-
justment result in fee revenues for a fiscal year 
that are less than the fee revenues established 
for the prior fiscal year. 
‘‘(3) ANNUAL FEE SETTING FOR ADVISORY RE-
VIEW.— 
‘‘(A) IN GENERAL.—Not later than August 
1 of each fiscal year, the Secretary shall estab-
lish for the next fiscal year the DTC advertise-
ment advisory review fee under subsection 
(a)(1), based on the revenue amounts estab-
lished under subsection (b), the adjustments 
provided under paragraphs (1) and (2), and the 
number of DTC advertisements identified pur-
suant to subsection (a)(1)(C), excluding allow-
able previously-paid carry over submissions. 
The annual advisory review fee shall be estab-
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lished by dividing the fee revenue for a fiscal 
year (as adjusted pursuant to this subsection) 
by the number of DTC advertisements so iden-
tified, excluding allowable previously-paid carry 
over submissions. 
‘‘(B) FISCAL YEAR 2008 FEE LIMIT.—Not-
withstanding subsection (b) and the adjust-
ments pursuant to this subsection, the fee es-
tablished under subparagraph (A) for fiscal 
year 2008 may not be more than $83,000 per 
submission for advisory review. 
‘‘(C) 
ANNUAL
FEE
LIMIT.—Notwith-
standing subsection (b) and the adjustments 
pursuant to this subsection, the fee established 
under subparagraph (A) for a fiscal year after 
fiscal year 2008 may not be more than 50 per-
cent more than the fee established for the prior 
fiscal year. 
‘‘(D) LIMIT.—The total amount of fees ob-
ligated for a fiscal year may not exceed the 
total costs for such fiscal year for the resources 
allocated for the process for the advisory review 
of prescription drug advertising. 
‘‘(d) OPERATING RESERVES.— 
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‘‘(1) IN GENERAL.—The Secretary shall estab-
lish in the Food and Drug Administration salaries 
and expenses appropriation account without fiscal 
year limitation a Direct-to-Consumer Advisory Re-
view Operating Reserve, of at least $6,250,000 in 
fiscal year 2008, to continue the program under this 
section in the event the fees collected in any subse-
quent fiscal year pursuant to subsection (a)(1) do 
not generate the fee revenue amount established for 
that fiscal year. 
‘‘(2) FEE SETTING.—The Secretary shall estab-
lish the operating reserve fee under subsection 
(a)(2)(A) for each person required to pay the fee by 
multiplying the number of DTC advertisements iden-
tified by that person pursuant to subsection 
(a)(1)(C) by the advisory review fee established pur-
suant to subsection (c)(3) for that fiscal year, except 
that in no case shall the operating reserve fee as-
sessed be less than the operating reserve fee as-
sessed if the person had first participated in the pro-
gram under this section in fiscal year 2008. 
‘‘(3) USE OF OPERATING RESERVE.—The Sec-
retary may use funds from the reserves only to the 
extent necessary in any fiscal year to make up the 
difference between the fee revenue amount estab-
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lished for that fiscal year under subsections (b) and 
(c) and the amount of fees actually collected for that 
fiscal year pursuant to subsection (a)(1), or to pay 
costs of ending the program under this section if it 
is terminated pursuant to subsection (f) or not reau-
thorized beyond fiscal year 2012. 
‘‘(4) REFUND
OF
OPERATING
RESERVES.— 
Within 120 days of the end of fiscal year 2012, or 
if the program under this section ends early pursu-
ant to subsection (f), the Secretary, after setting 
aside sufficient operating reserve amounts to termi-
nate the program under this section, shall refund all 
amounts remaining in the operating reserve on a pro 
rata basis to each person that paid an operating re-
serve fee assessment. In no event shall the refund to 
any person exceed the total amount of operating re-
serve fees paid by such person pursuant to sub-
section (a)(2). 
‘‘(e) EFFECT OF FAILURE TO PAY FEES.—Notwith-
standing any other requirement, a submission for 
prebroadcast advisory review of a DTC advertisement sub-
mitted by a person subject to fees under subsection (a) 
shall be considered incomplete and shall not be accepted 
for review by the Secretary until all fees owed by such 
person under this section have been paid. 
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‘‘(f) EFFECT OF INADEQUATE FUNDING OF PRO-
GRAM.— 
‘‘(1) INITIAL
FUNDING.—If on November 1, 
2007, or 120 days after enactment of this provision, 
whichever is later, the Secretary has not received at 
least $11,250,000 in advisory review fees and oper-
ating reserve fees combined, the program under this 
section shall not commence and all collected fees 
shall be refunded. 
‘‘(2) LATER FISCAL YEARS.—Beginning in fis-
cal year 2009, if, on November 1 of the fiscal year, 
the combination of the operating reserves, annual fee 
revenues from that fiscal year, and unobligated fee 
revenues from prior fiscal years falls below 
$9,000,000, adjusted for inflation (as described in 
subsection (c)(1)), the program under this section 
shall cease to exist, and the Secretary shall notify all 
participants, retain any money from the unused ad-
visory review fees and the operating reserves needed 
to close down the program under this section, and 
refund the remainder of the unused fees and oper-
ating reserves. To the extent required to close down 
the program under this section, the Secretary shall 
first use unobligated advisory review fee revenues 
from prior fiscal years, then the operating reserves, 
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and finally, unused advisory review fees from the rel-
evant fiscal year. 
‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) of this section shall be collected and 
available for obligation only to the extent and in the 
amount provided in advance in appropriations Acts. 
Such fees are authorized to remain available until 
expended. Such sums as may be necessary may be 
transferred from the Food and Drug Administration 
salaries and expenses appropriation account without 
fiscal year limitation to such appropriation account 
for salaries and expenses with such fiscal year limi-
tation. The sums transferred shall be available solely 
for the process for the advisory review of prescrip-
tion drug advertising. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATION 
ACTS.— 
‘‘(A) IN
GENERAL.—The fees authorized 
by this section— 
‘‘(i) shall be retained in each fiscal 
year in an amount not to exceed the 
amount specified in appropriation Acts, or 
otherwise made available for obligation for 
such fiscal year; and 
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‘‘(ii) shall be available for obligation 
only if the amounts appropriated as budget 
authority for such fiscal year are sufficient 
to support a number of full-time equivalent 
review employees that is not fewer than the 
number of such employees supported in fis-
cal year 2007. 
‘‘(B) REVIEW EMPLOYEES.—For purposes 
of subparagraph (A)(ii), the term ‘full-time 
equivalent review employees’ means the total 
combined number of full-time equivalent em-
ployees in— 
‘‘(i) the Center for Drug Evaluation 
and Research, Division of Drug Marketing, 
Advertising, and Communications, Food 
and Drug Administration; and 
‘‘(ii) the Center for Biologics Evalua-
tion and Research, Advertising and Pro-
motional Labeling Branch, Food and Drug 
Administration. 
‘‘(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 
amount determined under subsection (b) for the fis-
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cal year, as adjusted pursuant to subsection (c) and 
paragraph (4) of this subsection, plus amounts col-
lected for the reserve fund under subsection (d). 
‘‘(4) OFFSET.—Any amount of fees collected 
for a fiscal year under this section that exceeds the 
amount of fees specified in appropriation Acts for 
such fiscal year shall be credited to the appropria-
tion account of the Food and Drug Administration 
as provided in paragraph (1), and shall be sub-
tracted from the amount of fees that would other-
wise be collected under this section pursuant to ap-
propriation Acts for a subsequent fiscal year. 
‘‘(h) DEFINITIONS.—For purposes of this sub-
chapter: 
‘‘(1) The term ‘advisory review’ means review-
ing and providing advisory comments on a proposed 
advertisement prior to its initial public broadcast. 
‘‘(2) The term ‘advisory review fee’ has the 
meaning indicated for such term in subsection 
(a)(1)(D). 
‘‘(3) The term ‘carry over submission’ means a 
submission for an advisory review for which a fee 
was paid in one fiscal year that is submitted for re-
view in the following fiscal year. 
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‘‘(4) The term ‘direct-to-consumer television ad-
vertisement’ means an advertisement for a prescrip-
tion drug product as defined in section 735(3) in-
tended to be displayed on any television channel for 
less than 3 minutes. 
‘‘(5) The term ‘DTC advertisement’ has the 
meaning indicated for such term in subsection 
(a)(1)(A). 
‘‘(6) The term ‘operating reserve fee’ has the 
meaning indicated for such term in subsection 
(a)(2)(A). 
‘‘(7) The term ‘person’ includes an individual, 
partnership, corporation, and association, and any 
affiliate thereof or successor in interest. 
‘‘(8) The term ‘prebroadcast advisory review’ 
has the meaning indicated for such term in sub-
section (a)(1)(A). 
‘‘(9) The term ‘process for the advisory review 
of prescription drug advertising’ means the activities 
necessary to review and provide advisory comments 
on DTC advertisements prior to public broadcast 
and, to the extent the Secretary has additional staff 
resources available under the program under this 
section that are not necessary for the advisory re-
view of DTC advertisements, the activities necessary 
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to review and provide advisory comments on other 
proposed advertisements and promotional material 
prior to public broadcast. 
‘‘(10) The term ‘resources allocated for the 
process for the advisory review of prescription drug 
advertising’ means the expenses incurred in connec-
tion with the process for the advisory review of pre-
scription drug advertising for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees, and costs related to such officers, em-
ployees, and committees, and to contracts with 
such contractors; 
‘‘(B) management of information, and the 
acquisition, maintenance, and repair of com-
puter resources; 
‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific 
equipment, and other necessary materials and 
supplies; 
‘‘(D) collection of fees under this section 
and accounting for resources allocated for the 
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advisory review of prescription drug advertising; 
and 
‘‘(E) closing down the program under this 
section pursuant to subsection (f)(2) if that be-
comes necessary. 
‘‘(11) The term ‘resubmission’ means a subse-
quent submission for advisory review of a direct-to- 
consumer television advertisement that has been re-
vised in response to the Secretary’s comments on an 
original submission. A resubmission may not intro-
duce significant new concepts or creative themes into 
the television advertisement. 
‘‘(12) The term ‘submission for advisory review’ 
means an original submission of a direct-to-con-
sumer television advertisement for which the sponsor 
voluntarily requests advisory comments before the 
advertisement is publicly disseminated.’’. 
SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS. 
(a) PERFORMANCE REPORT.—Beginning with fiscal 
year 2008, not later than 120 days after the end of each 
fiscal year for which fees are collected under part 2 of 
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary 
of Health and Human Services (referred to in this section 
as the ‘‘Secretary’’) shall prepare and submit to the Com-
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mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report concerning 
the progress of the Food and Drug Administration in 
achieving the goals identified in the letters described in 
section 502(4) of the Prescription Drug User Fee Amend-
ments of 2002 (Subtitle A of title V of Public Law 107– 
188) during such fiscal year and the future plans of the 
Food and Drug Administration for meeting the goals. 
(b) FISCAL REPORT.—Beginning with fiscal year 
2008, not later than 120 days after the end of each fiscal 
year for which fees are collected under the part described 
in subsection (a), the Secretary shall prepare and submit 
to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report on the 
implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administra-
tion, of the fees collected for such fiscal year. 
(c) REAUTHORIZATION.— 
(1) 
CONSULTATION.—In 
developing 
rec-
ommendations to present to the Congress with re-
spect to the goals, and plans for meeting the goals, 
for the process for the review of human drug appli-
cations for the first 5 fiscal years after fiscal year 
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