justment for changes in inspection activities ap-
plied in setting fees and revenue amounts for 
fiscal year 2011 and to make recommendations, 
if warranted, for future changes in the method-
ology for calculating the adjustment. After re-
view of the recommendations, the Secretary 
shall, if warranted, make appropriate changes 
to the methodology, and the changes shall be ef-
fective for each of the fiscal years 2012 through 
2014. The Secretary shall not make any adjust-
ment for changes in inspection activities for any 
fiscal year after 2011 unless such study has 
been completed. 
‘‘(3) RENT AND RENT-RELATED COST ADJUST-
MENT.—For fiscal year 2012 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 
(c)(1) if actual costs paid for rent and rent-related 
expenses for the preceding fiscal year are less than 
estimates made for such year in fiscal year 2008. 
Any reduction made under this paragraph shall not 
exceed the amount by which such costs fall below the 
estimates made in fiscal year 2008 for such fiscal 
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year, and shall not exceed $11,721,000 for any fiscal 
year. 
‘‘(4) FINAL
YEAR
ADJUSTMENT.—For fiscal 
year 2014, the Secretary may, in addition to adjust-
ments under paragraphs (1), (2), (3), and (5), fur-
ther increase the fee revenues and fees established in 
subsection (c) if such an adjustment is necessary to 
provide for not more than 3 months of operating re-
serves of carryover user fees for inspections de-
scribed in subsection (a) for the first 3 months of 
fiscal year 2015. If such an adjustment is necessary, 
the rationale for the amount of the increase shall be 
contained in the annual notice establishing fee reve-
nues and fees for fiscal year 2014. If the Secretary 
has carryover balances for such inspections in excess 
of 3 months of such operating reserves, the adjust-
ment under this paragraph shall not be made. 
‘‘(5) COST ESTIMATE ADJUSTMENT.—For fiscal 
year 2011 and subsequent fiscal years, the Secretary 
by notice, published in the Federal Register, shall— 
‘‘(A) provide an estimate of the amount of 
the total increases described in subsection (a) 
for such fiscal year; and 
‘‘(B) after making adjustments under 
paragraphs (1), (2), and (3), adjust the reve-
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nues established in subsection (c)(1) to be equal 
to such amount. 
‘‘(6) LIMIT.—The total amount of fees charged, 
as adjusted under this subsection, for a fiscal year 
may not exceed the total increases described in sub-
section (a) for such fiscal year. 
‘‘(e) FEE WAIVER OR REDUCTION..— 
‘‘(1) IN GENERAL.—The Secretary may grant 
to a person a waiver from, or a reduction of, one or 
more fees under this section if the Secretary finds 
that— 
‘‘(A) such waiver or reduction is necessary 
to protect the public health; or 
‘‘(B) the assessment of the fee would im-
pose significant financial hardship because of 
limited resources available to such person or 
other circumstances. 
‘‘(2) SPECIAL RULES FOR POSITRON EMISSION 
TOMOGRAPHY DRUGS.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), each person who is named 
as the applicant in an approved human drug 
application for a positron emission tomography 
drug shall be subject under paragraph (a) to 
one-sixth of an annual registration fee with re-
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spect to each establishment identified in the ap-
plication as producing positron emission tomog-
raphy drugs under the approved application. 
‘‘(B) EXCEPTION
FROM
ANNUAL
REG-
ISTRATION FEE.—Each person who is named as 
the applicant in an application described in sub-
paragraph (A) shall be granted a waiver under 
paragraph (1) from an annual registration fee 
under subsection (a) for a fiscal year if the per-
son certifies to the Secretary, at a time speci-
fied by the Secretary and using procedures 
specified by the Secretary, that— 
‘‘(i) the person is a not-for-profit 
medical center that has only 1 establish-
ment for the production of positron emis-
sion tomography drugs; and 
‘‘(ii) at least 95 percent of the total 
number of doses of each positron emission 
tomography drug produced by such estab-
lishment during such fiscal year will be 
used within the medical center. 
‘‘(3) DESIGNATED ORPHAN DRUG.—An estab-
lishment registered under section 510 shall, with re-
spect to the manufacture, preparation, propagation, 
compounding, or processing of drugs, be granted a 
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waiver under paragraph (1) from a fee under sub-
section (a) if all drugs manufactured, prepared, 
propagated, compounded, or processed by the estab-
lishment are designated as a drug for a rare disease 
or condition pursuant to section 526. The preceding 
sentence shall not apply if the application approved 
under section 505 for any such drug includes an in-
dication for a disease or condition other than such 
a rare disease or condition. 
‘‘(f) LIMITATIONS.— 
‘‘(1) IN GENERAL.—Fees under subsection (a) 
shall be refunded for a fiscal year beginning after 
fiscal year 2010 unless appropriations for salaries 
and expenses of the Food and Drug Administration 
for such fiscal year (excluding the amount of fees 
appropriated for such fiscal year) are equal to or 
greater than the amount of appropriations for the 
salaries and expenses of the Food and Drug Admin-
istration for the fiscal year 2010 (excluding the 
amount of fees appropriated for such fiscal year) 
multiplied by the adjustment factor applicable to the 
fiscal year involved. 
‘‘(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 
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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 
registration under subsection (b), (c), (d), or (i) of 
section 510 at any time in such 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. 
‘‘(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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