Page:United States Statutes at Large Volume 98 Part 2.djvu/442

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PUBLIC LAW 98-000—MMMM. DD, 1984

98 STAT. 1602

21 USC 360e.

Fees.

PUBLIC LAW 98-417—SEPT. 24, 1984

permitted or, if commercial marketing was permitted and later revoked pending further proceedings as a result of such objections, ending on the date such proceedings were finally resolved and commercial marketing was permitted. "(3)(A) In the case of a product which is a medical device, the term means the period described in subparagraph (B) to which the limitation described in paragraph (4) applies. "(B) The regulatory review period for a medical device is the sum of^ "(i) the period beginning on the date a clinical investigation on humans involving the device was begun and ending on the date an application was initially submitted with respect to the device under section 515, and "(ii) the period beginning on the date an application was initially submitted with respect to the device under section 515 and ending on the date such application was approved under such Act or the period beginning on the date a notice of completion of a product development protocol was initially submitted under section 515(f)(5) and ending on the date the protocol was declared completed under section 515(f)(6). "(4) A period determined under any of the preceding paragraphs is subject to the following limitations: "(A) If the patent involved was issued after the date of the enactment of this section, the period of extension determined on the basis of the regulatory review period determined under any such paragraph may not exceed five years. "(B) If the patent involved was issued before the date of the enactment of this section and— "(i) no request for an exemption described in paragraph (1)(B) was submitted, "(ii) no major health or environmental effects test described in paragraph (2) was initiated and no petition for a regulation or application for registration described in such paragraph was submitted, or "(iii) no clinical investigation described in paragraph (3) was begun or product development protocol described in such paragraph was submittted, before such date for the approved product the period of extension determined on the basis of the regulatory review period determined under any such paragraph may not exceed five years. "(C) If the patent involved was issued before the date of the enactment of this section and if an action described in subparagraph (B) was taken before the date of the enactment of this section with respect to the approved product and the commercial marketing or use of the product has not been approved before such date, the period of extension determined on the basis of the regulatory review period determined under such paragraph may not exceed two years. "(h) The Commissioner may establish such fees as the Commissioner determines appropriate to cover the costs to the Office of receiving and acting upon applications under this section.". (b) The analysis for chapter 14 of title 35 of the United States Code is amended by adding at the end thereof the following: