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 (a)(l)(A) 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 business 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)(1) shall be increased publication. jjy tjjg 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 FEE ADJUSTMENT. —Subject to the amount appropriated for a fiscal year under subsection (g), the Secretary shall, within 60 days after the end of each fiscal year beginning after October 1, 1992, adjust the fees established by the schedule in subsection (b)(1) 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 maintain 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 himian 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 circimistances, "(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 applications for such person, or "(4) assessment of the fee for an application or a supplement filed under section 505(b)(1) pertaining to a drug containing 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 (a)(D- In making the finding in paragraph (3), the Secretary may use standard costs. -
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