Page:United States Statutes at Large Volume 111 Part 3.djvu/220

 HI STAT. 2308 PUBLIC LAW 105-115—NOV. 21, 1997 have been reported in accordance with the requirements of the Secretary for filing. "(e) DELAY OF EFFECTIVE DATE FOR CERTAIN APPLICATION.— If the Secretary determines that the acceptance or approval of an application under section 505(b)(2) or 505(j) for a new drug may occur after submission of reports of pediatric studies under this section, which were submitted prior to the expiration of the patent (including any patent extension) or the applicable period under clauses (ii) through (iv) of section 505(c)(3)(D) or clauses (ii) through (iv) of section 5050*)(4)(D), but before the Secretary has determined whether the requirements of subsection (d) have been satisfied, the Secretary shall delay the acceptsince or approval under section 505(b)(2) or 505(j) until the determination under subsection (d) is made, but any such delay shall not exceed 90 days. In the event that requirements of this section are satisfied, the applicable six-month period under subsection (a) or (c) shall be deemed to have been running during the period of delay. " (f) NOTICE OF DETERMINATIONS ON STUDIES REQUIREMENT.— The Secretary shall publish a notice of any determination that the requirements of subsection (d) have been met and that submissions and approvals under subsection (b)(2) or (j) of section 505 for a drug will be subject to the provisions of this section. "(g) DEFINITIONS.—As used in this section, the term 'pediatric studies' or 'studies' means at least one clinical investigation (that, at the Secretary's discretion, may include pharmacokinetic studies) in pediatric age groups in which a drug is anticipated to be used. "(h) LIMITATIONS.—^A drug to which the six-month period under subsection (a) or (b) has already been applied— "(1) may receive an additional six-month period under subsection (c)(l)(A)(ii) for a supplemental application if all other requirements under this section are satisfied, except that such a drug may not receive any additional such period under subsection (c)(2); and "(2) may not receive any additional such period under subsection (c)(1)(B). "(i) RELATIONSHIP TO REGULATIONS.— Notwithstanding any other provision of law, if any pediatric study is required pursuant to regulations promulgated by the Secretary and such study meets the completeness, timeliness, and other requirements of this section, such study shall be deemed to satisfy the requirement for market exclusivity pursuant to this section. "(j) SUNSET. — ^A drug may not receive any six-month period under subsection (a) or (c) unless the application for the drug under section 505(b)(1) is submitted on or before January 1, 2002. After January 1, 2002, a drug shall receive a six-month period under subsection (c) if— "(1) the drug was in commercial distribution as of the date of enactment of the Food and Drug Administration Modernization Act of 1997; "(2) the drug was included by the Secretary on the list under subsection (b) as of January 1, 2002; "(3) the Secretary determines that there is a continuing need for information relating to the use of the drug in the pediatric population and that the drug may provide health benefits in that population; and "(4) all requirements of this section are met.

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