106 STAT. 4496 PUBLIC LAW 102-571—OCT. 29, 1992

or delivered for introduction into interstate commerce shall
pay one-half the amount of the fee for human drug applications
it submits and shall pay the entire amount of the fee for
supplements it submits. Such a business shall not be required
to pay any portion of any fee required under subsection (aXIXA)
until 1 year after the date of the submission of the application
involved. For purposes of this paragraph, one business is an
affiliate of another business when, directly or indirectly, one
business controls, or has the power to control, the other busi-
ness or a third party controls, or has the power to control,
both businesses.

"(c) INCREASES AND ADJUSTMENTS.—

Federal "(1) REVENUE INCREASE.—The total fee revenues estab-

Register, lished by the schedule in subsection (b)(l) shall be increased

pubhcation. by the Secretary by notice, published in the Federal Register,

for a fiscal year to reflect the greater of—

"(A) the total percentage increase that occurred during

the preceding fiscal year in the Consumer Price Index

for all urban consumers (all items; U.S. city average), or
"(B) the total percentage increase for such fiscal year

in basic pay under the General Schedule in accordance

with section 5332 of title 5, United States Code, as adjusted

by any locality-based comparability payment pursuant to

section 5304 of such title for Federal employees stationed

in the District of Columbia.

"(2) ANNUAL PEE ADJUSTMENT.—Subject to the amount
appropriated for a fiscal year under subsection (g), the Secretary
snail, within 60 days after the end of each fiscal year beginning
after October 1, 1992, adjust the fees established by the sched-
ule in subsection (bXD for the following fiscal year to achieve
the total fee revenues, as may be increased under paragraph
(1). Such fees shall be adjusted under this paragraph to main-
tain the proportions established in such schedule.

"(3) LIMIT.—The total amount of fees charged, as adjusted
under paragraph (2), for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated for
the process for the review of human drug applications,
"(d) FEE WAIVER OR REDUCTION.—The Secretary shall grant
a waiver from or a reduction of 1 or more fees under subsection
(a) where the Secretary finds that—

"(1) such waiver or reduction is necessary to protect the
public health,

"(2) the assessment of the fee would present a significant
barrier to innovation because of limited resources available
to such person or other circumstances,

"(3) the fees to be paid by such person will exceed the
anticipated present and future costs incurred by the Secretary
in conducting the process for the review of human drug applica-
tions for such person, or

"(4) assessment of the fee for an application or a supple-
ment filed under section 505(b)(l) pertaining to a drug contain-
ing an active ingredient would be inequitable because an
application for a product containing the same active ingredient
filed by another person under section 505(b)(2) could not be
assessed fees under subsection (aXD-

In making the finding in paragraph (3), the Secretary may use
standard costs.