Page:United States Statutes at Large Volume 116 Part 2.djvu/810

 116 STAT. 1592 PUBLIC LAW 107-250—OCT. 26, 2002 "(ii) For a premarket report, a fee equal to the fee that appHes under clause (i). "(iii) For a panel track supplement, a fee equal to the fee that applies under clause (i). "(iv) For a 180-day supplement, a fee equal to 21.5 percent of the fee that applies under clause (i), subject to any adjustment under subsection (c)(3). "(v) For a real-time supplement, a fee equal to 7.2 percent of the fee that applies under clause (i). "(vi) For an efficacy supplement, a fee equal to the fee that applies under clause (i). "(vii) For a premarket notification submission, a fee equal to 1.42 percent of the fee that applies under clause (i), subject to any adjustment under subsection (c)(3) and any adjustment under subsection (e)(2)(C)(ii). "(B) EXCEPTIONS.— " (i) HUMANITARIAN DEVICE EXEMPTION. —An application under section 520(m) is not subject to any fee under subparagraph (A). "(ii) FURTHER MANUFACTURING USE.— No fee shall be required under subparagraph (A) for the submission of a premarket application under section 351 of the Public Health Service Act for a product licensed for further manufacturing use only. "(iii) STATE OR FEDERAL GOVERNMENT SPONSORS. — No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, or premarket notification submission submitted by a State or Federal Government entity unless the device involved is to be distributed commercially. "(iv) PREMARKET NOTIFICATIONS BY THIRD PAR- TIES.— No fee shall be required under subparagraph (A) for a premarket notification submission reviewed by an accredited person pursuant to section 523. "(v) PEDIATRIC CONDITIONS OF USE. — "(I) IN GENERAL.—No fee shall be required under subparagraph (A) for a premarket application, premarket report, or premarket notification submission if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population. "(II) SUBSEQUENT PROPOSAL OF ADULT CONDI- TIONS OF USE. —In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application. "(C) PAYMENT. —The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, or premarket notification submission except that invoices for applications submitted

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