plete, the establishment is deemed to have failed to 
register in accordance with section 510.’’. 
(g) 
CONDITIONS.—Section 
738(g) 
(21 
U.S.C. 
379j(g)) is amended— 
(1) by striking paragraph (1) and inserting the 
following: 
‘‘(1) PERFORMANCE GOALS; TERMINATION OF 
PROGRAM.—With respect to the amount that, under 
the salaries and expenses account of the Food and 
Drug Administration, is appropriated for a fiscal 
year for devices and radiological products, fees may 
not be assessed under subsection (a) for the fiscal 
year, and the Secretary is not expected to meet any 
performance goals identified for the fiscal year, if— 
‘‘(A) the amount so appropriated for the 
fiscal year, excluding the amount of fees appro-
priated for the fiscal year, is more than 1 per-
cent less than $205,720,000 multiplied by the 
adjustment factor applicable to such fiscal year; 
or 
‘‘(B) fees were not assessed under sub-
section (a) for the previous fiscal year.’’; and 
(2) by amending paragraph (2) to read as fol-
lows: 
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‘‘(2) AUTHORITY.—If the Secretary does not 
assess fees under subsection (a) during any portion 
of a fiscal year because of paragraph (1) and if at 
a later date in such fiscal year the Secretary may as-
sess such fees, the Secretary may assess and collect 
such fees, without any modification in the rate for 
premarket applications, supplements, premarket re-
ports, premarket notification submissions, 30-day 
notices, requests for classification information, peri-
odic reporting concerning a class III device, and es-
tablishment registrations at any time in such fiscal 
year, notwithstanding the provisions of subsection 
(a) relating to the date fees are to be paid.’’. 
(h) CREDITING AND AVAILABILITY OF FEES.— 
(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
Section 738(h)(3) (21 U.S.C. 379j(h)(3)) is amend-
ed to read as follows: 
‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.— 
There are authorized to be appropriated for fees 
under this section— 
‘‘(A) $48,431,000 for fiscal year 2008; 
‘‘(B) $52,547,000 for fiscal year 2009; 
‘‘(C) $57,014,000 for fiscal year 2010; 
‘‘(D) $61,860,000 for fiscal year 2011; 
and 
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‘‘(E) $67,118,000 for fiscal year 2012.’’. 
(2) OFFSET.—Section 738(h)(4) (21 U.S.C. 
379j(h)(3)) is amended to read as follows: 
‘‘(4) OFFSET.—If the cumulative amount of 
fees collected during fiscal years 2008, 2009, and 
2010, added to the amount estimated to be collected 
for fiscal year 2011, which estimate shall be based 
upon the amount of fees received by the Secretary 
through June 30, 2011, exceeds the amount of fees 
specified in aggregate in paragraph (3) for these 
four fiscal years, the aggregate amount in excess 
shall be credited to the appropriation account of the 
Food and Drug Administration as provided in para-
graph (1), and shall be subtracted from the amount 
of fees that would otherwise be authorized to be col-
lected under this section pursuant to appropriation 
Acts for fiscal year 2012.’’. 
SEC. 213. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Part 3 of subchapter C of chapter VII is amended 
by inserting after section 738 the following: 
‘‘SEC. 738A. REAUTHORIZATION; REPORTING REQUIRE-
MENTS. 
‘‘(a) REPORTS.— 
‘‘(1) PERFORMANCE REPORT.—For fiscal years 
2008 through 2012, not later than 120 days after 
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the end of each fiscal year during which fees are col-
lected under this part, the Secretary shall prepare 
and submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives, a report concerning the progress of 
the Food and Drug Administration in achieving the 
goals identified in the letters described in section 
201(c) of the Food and Drug Administration 
Amendments Act of 2007 during such fiscal year 
and the future plans of the Food and Drug Adminis-
tration 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 re-
sponse on all device premarket applications and re-
ports, supplements, and premarket notifications in 
the cohort. 
‘‘(2) FISCAL REPORT.—For fiscal years 2008 
through 2012, not later than 120 days after the end 
of each fiscal year during which fees are collected 
under this part, the Secretary shall prepare and sub-
mit to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representa-
tives, a report on the implementation of the author-
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ity for such fees during such fiscal year and the use, 
by the Food and Drug Administration, of the fees 
collected during such fiscal year for which the report 
is made. 
‘‘(3) PUBLIC
AVAILABILITY.—The Secretary 
shall make the reports required under paragraphs 
(1) and (2) available to the public on the Internet 
Web site of the Food and Drug Administration. 
‘‘(b) REAUTHORIZATION.— 
‘‘(1) 
CONSULTATION.—In 
developing 
rec-
ommendations to present to Congress with respect to 
the goals, and plans for meeting the goals, for the 
process for the review of device applications 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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