equipment, and other necessary materials and 
supplies; 
‘‘(D) collection of fees under this section 
and accounting for resources allocated for the 
advisory review of prescription drug advertising; 
and 
‘‘(E) terminating the program under this 
section pursuant to subsection (f)(2) if that be-
comes necessary. 
‘‘(10) 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. 
‘‘(11) 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. 
Part 2 of subchapter C of chapter VII (21 U.S.C. 
379g et seq.), as amended by section 104, is further 
amended by inserting after section 736A the following: 
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‘‘SEC. 736B. REAUTHORIZATION; REPORTING REQUIRE-
MENTS. 
‘‘(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 this part, 
the Secretary shall prepare and submit to the Committee 
on Energy and Commerce of the House of Representatives 
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 101(c) 
of the Food and Drug Administration Amendments Act 
of 2007 during such fiscal year and the future plans of 
the Food and Drug Administration for meeting the goals. 
The report for a fiscal year shall include information on 
all previous cohorts for which the Secretary has not given 
a complete response on all human drug applications and 
supplements in the cohort. 
‘‘(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 this part, the Sec-
retary shall prepare and submit to the Committee on En-
ergy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and Pen-
sions of the Senate a report on the implementation of the 
authority for such fees during such fiscal year and the 
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use, by the Food and Drug Administration, of the fees 
collected for such fiscal year. 
‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 
make the reports required under subsections (a) and (b) 
available to the public on the Internet Web site of the 
Food and Drug Administration. 
‘‘(d) 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 
2012, and for the reauthorization of this part for 
such fiscal years, the Secretary shall consult with— 
‘‘(A) the Committee on Energy and Com-
merce of the House of Representatives; 
‘‘(B) the Committee on Health, Education, 
Labor, and Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
‘‘(D) health care professionals; 
‘‘(E) representatives of patient and con-
sumer advocacy groups; and 
‘‘(F) the regulated industry. 
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‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning 
negotiations with the regulated industry on the reau-
thorization of this part, the Secretary shall— 
‘‘(A) publish a notice in the Federal Reg-
ister requesting public input on the reauthoriza-
tion; 
‘‘(B) hold a public meeting at which the 
public may present its views on the reauthoriza-
tion, including specific suggestions for changes 
to the goals referred to in subsection (a); 
‘‘(C) provide a period of 30 days after the 
public meeting to obtain written comments from 
the public suggesting changes to this part; and 
‘‘(D) publish the comments on the Food 
and Drug Administration’s Internet Web site. 
‘‘(3) PERIODIC CONSULTATION.—Not less fre-
quently than once every month during negotiations 
with the regulated industry, the Secretary shall hold 
discussions with representatives of patient and con-
sumer advocacy groups to continue discussions of 
their views on the reauthorization and their sugges-
tions for changes to this part as expressed under 
paragraph (2). 
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‘‘(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.— 
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‘‘(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 
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(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. 
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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 
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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 
device, including an establishment that sterilizes 
or otherwise makes such article for or on behalf 
of a specification developer or any other person. 
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‘‘(B) 
SINGLE-USE
DEVICE
REPROC-
ESSOR.—An establishment that, within the 
meaning of section 201(ll)(2)(A), performs ad-
ditional processing and manufacturing oper-
ations on a single-use device that has previously 
been used on a patient. 
‘‘(C) SPECIFICATION DEVELOPER.—An es-
tablishment that develops specifications for a 
device that is distributed under the establish-
ment’s name but which performs no manufac-
turing, including an establishment that, in addi-
tion to developing specifications, also arranges 
for the manufacturing of devices labeled with 
another establishment’s name by a contract 
manufacturer.’’. 
SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES. 
(a) TYPES OF FEES.— 
(1) IN GENERAL.—Section 738(a) (21 U.S.C. 
379j(a)) is amended— 
(A) in paragraph (1), by striking ‘‘Begin-
ning on the date of the enactment of the Med-
ical Device User Fee and Modernization Act of 
2002’’ and inserting ‘‘Beginning in fiscal year 
2008’’; and 
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(B) by amending the designation and 
heading of paragraph (2) to read as follows: 
‘‘(2) PREMARKET
APPLICATION, PREMARKET 
REPORT, SUPPLEMENT, AND SUBMISSION FEE, AND 
ANNUAL
FEE
FOR
PERIODIC
REPORTING
CON-
CERNING A CLASS III DEVICE.—’’. 
(2) FEE AMOUNTS.—Section 738(a)(2)(A) (21 
U.S.C. 379j(a)(2)(A)) is amended— 
(A) in clause (iii), by striking ‘‘a fee equal 
to the fee that applies’’ and inserting ‘‘a fee 
equal to 75 percent of the fee that applies’’; 
(B) in clause (iv), by striking ‘‘21.5 per-
cent’’ and inserting ‘‘15 percent’’; 
(C) in clause (v), by striking ‘‘7.2 percent’’ 
and inserting ‘‘7 percent’’; 
(D) by redesignating clauses (vi) and (vii) 
as clauses (vii) and (viii), respectively; 
(E) by inserting after clause (v) the fol-
lowing: 
‘‘(vi) For a 30-day notice, a fee equal 
to 1.6 percent of the fee that applies under 
clause (i).’’; 
(F) in clause (viii), as so redesignated— 
(i) by striking ‘‘1.42 percent’’ and in-
serting ‘‘1.84 percent’’; and 
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(ii) by striking ‘‘, subject to any ad-
justment under subsection (e)(2)(C)(ii)’’; 
and 
(G) by inserting after such clause (viii) the 
following: 
‘‘(ix) For a request for classification 
information, a fee equal to 1.35 percent of 
the fee that applies under clause (i). 
‘‘(x) For periodic reporting concerning 
a class III device, an annual fee equal to 
3.5 percent of the fee that applies under 
clause (i).’’. 
(3) 
PAYMENT.—Section 
738(a)(2)(C) 
(21 
U.S.C. 379j(a)(2)(C)) is amended to read as follows: 
‘‘(C) PAYMENT.—The fee required by sub-
paragraph (A) shall be due upon submission of 
the premarket application, premarket report, 
supplement, premarket notification submission, 
30-day notice, request for classification infor-
mation, or periodic reporting concerning a class 
III device. Applicants submitting portions of 
applications pursuant to section 515(c)(4) shall 
pay such fees upon submission of the first por-
tion of such applications.’’. 
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