retary shall establish for the next fiscal year the 
DTC advertisement advisory review fee under 
subsection 
(a)(1), 
based 
on 
the 
revenue 
amounts established under subsection (b), the 
adjustments provided under paragraphs (1) and 
(2), and the number of DTC advertisements 
identified pursuant to subsection (a)(1)(C), ex-
cluding allowable previously-paid carry over 
submissions. The annual advisory review fee 
shall be established by dividing the fee revenue 
for a fiscal year (as adjusted pursuant to this 
subsection) by the number of DTC advertise-
ments so identified, excluding allowable pre-
viously-paid carry over submissions under sub-
section (a)(1)(F)(i). 
‘‘(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.— 
‘‘(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-
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 after the end of fiscal year 2012, 
or if the program under this section ends early pur-
suant 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 advisory 
review of a DTC advertisement submitted by a person sub-
ject to fees under subsection (a) shall be considered incom-
plete and shall not be accepted for review by the Secretary 
until all fees owed by such person under this section have 
been paid. 
‘‘(f) EFFECT OF INADEQUATE FUNDING OF PRO-
GRAM.— 
‘‘(1) INITIAL
FUNDING.—If on November 1, 
2007, or 120 days after the date of the enactment 
of the Food and Drug Administration Amendments 
Act of 2007, whichever is later, the Secretary has 
not received at least $11,250,000 in advisory review 
fees and operating reserve fees combined, the pro-
gram 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 terminate, and the Secretary shall notify all 
participants, retain any money from the unused ad-
visory review fees and the operating reserves needed 
to terminate the program, and refund the remainder 
of the unused fees and operating reserves. To the ex-
tent required to terminate the program, the Sec-
retary shall first use unobligated advisory review fee 
revenues from prior fiscal years, then the operating 
reserves, and finally, unused advisory review fees 
from the relevant fiscal year. 
‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. The 
sums transferred shall be available solely for the 
process for the advisory review of prescription 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 
‘‘(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
tions for changes to this part as expressed under 
paragraph (2). 
‘‘(4) 
PUBLIC
REVIEW
OF
RECOMMENDA-
TIONS.—After negotiations with the regulated indus-
try, the Secretary shall— 
‘‘(A) present the recommendations devel-
oped under paragraph (1) to the Congressional 
committees specified in such paragraph; 
‘‘(B) publish such recommendations in the 
Federal Register; 
‘‘(C) provide for a period of 30 days for 
the public to provide written comments on such 
recommendations; 
‘‘(D) hold a meeting at which the public 
may present its views on such recommenda-
tions; and 
‘‘(E) after consideration of such public 
views and comments, revise such recommenda-
tions as necessary. 
‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 
Not later than January 15, 2012, the Secretary 
shall transmit to the Congress the revised rec-
ommendations under paragraph (4), a summary of 
the views and comments received under such para-
graph, and any changes made to the recommenda-
tions in response to such views and comments. 
‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 
‘‘(A) PUBLIC AVAILABILITY.—Before pre-
senting the recommendations developed under 
paragraphs (1) through (5) to the Congress, the 
Secretary shall make publicly available, on the 
public Web site of the Food and Drug Adminis-
tration, minutes of all negotiation meetings con-
ducted under this subsection between the Food 
and Drug Administration and the regulated in-
dustry. 
‘‘(B) CONTENT.—The minutes described 
under subparagraph (A) shall summarize any 
substantive proposal made by any party to the 
negotiations as well as significant controversies 
or differences of opinion during the negotiations 
and their resolution.’’. 
SEC. 106. SUNSET DATES. 
(a) AUTHORIZATION.—The amendments made by 
sections 102, 103, and 104 cease to be effective October 
1, 2012. 
(b) REPORTING REQUIREMENTS.—The amendment 
made by section 105 ceases to be effective January 31, 
2013.
SEC. 107. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on October 1, 2007, or the date of the enactment of this 
Act, whichever is later, except that fees under part 2 of 
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act shall be assessed for all human drug 
applications received on or after October 1, 2007, regard-
less of the date of the enactment of this Act. 
SEC. 108. SAVINGS CLAUSE. 
Notwithstanding section 509 of the Prescription 
Drug User Fee Amendments of 2002 (21 U.S.C. 379g 
note), and notwithstanding the amendments made by this 
title, part 2 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act, as in effect on the day 
before the date of the enactment of this title, shall con-
tinue to be in effect with respect to human drug applica-
tions and supplements (as defined in such part as of such 
day) that on or after October 1, 2002, but before October 
1, 2007, were accepted by the Food and Drug Administra-
tion for filing with respect to assessing and collecting any 
fee required by such part for a fiscal year prior to fiscal 
year 2008.
SEC. 109. TECHNICAL AMENDMENT; CONFORMING AMEND-
MENT. 
(a) Section 739 (21 U.S.C. 379j–11) is amended in 
the matter preceding paragraph (1) by striking ‘‘sub-
chapter’’ and inserting ‘‘part’’. 
(b) Paragraph (11) of section 739 (21 U.S.C. 379j– 
11) is amended by striking ‘‘735(9)’’ and inserting 
‘‘735(11)’’. 
TITLE II—MEDICAL DEVICE 
USER FEE AMENDMENTS OF 2007 
SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Medical Device User Fee Amendments of 2007’’. 
(b) REFERENCES IN TITLE.—Except as otherwise 
specified, amendments made by this title to a section or 
other provision of law are amendments to such section or 
other provision of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.). 
(c) FINDING.—The Congress finds that the fees au-
thorized under the amendments made by this title will be 
dedicated toward expediting the process for the review of 
device applications and for assuring the safety and effec-
tiveness of devices, as set forth in the goals identified for 
purposes of part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act in the letters from 
the Secretary of Health and Human Services to the Chair-
man of the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Chairman of the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives, as set forth in the Congressional Record. 
Subtitle A—Fees Related to 
Medical Devices 
SEC. 211. DEFINITIONS. 
Section 737 is amended— 
(1) in the matter preceding paragraph (1), by 
striking ‘‘For purposes of this subchapter’’ and in-
serting ‘‘For purposes of this part’’; 
(2) by redesignating paragraphs (5), (6), (7), 
and (8) as paragraphs (8), (9), (10), and (12), re-
spectively; 
(3) by inserting after paragraph (4) the fol-
lowing: 
‘‘(5) The term ‘30-day notice’ means a notice 
under section 515(d)(6) that is limited to a request 
to make modifications to manufacturing procedures 
or methods of manufacture affecting the safety and 
effectiveness of the device. 
‘‘(6) The term ‘request for classification infor-
mation’ means a request made under section 513(g) 
for information respecting the class in which a de-
vice has been classified or the requirements applica-
ble to a device. 
‘‘(7) The term ‘annual fee’, for periodic report-
ing concerning a class III device, means the annual 
fee associated with periodic reports required by a 
premarket application approval order.’’; 
(4) in paragraph (10), as so redesignated— 
(A) by striking ‘‘April of the preceding fis-
cal year’’ and inserting ‘‘October of the pre-
ceding fiscal year’’; and 
(B) by striking ‘‘April 2002’’ and inserting 
‘‘October 2001’’; 
(5) by inserting after paragraph (10), as so 
amended, the following: 
‘‘(11) The term ‘person’ includes an affiliate 
thereof.’’; and 
(6) by inserting after paragraph (12), as so re-
designated, the following: 
‘‘(13) The term ‘establishment subject to a reg-
istration fee’ means an establishment that is re-
quired to register with the Secretary under section 
510 and is one of the following types of establish-
ments: 
‘‘(A) MANUFACTURER.—An establishment 
that makes by any means any article that is a