Page:United States Statutes at Large Volume 111 Part 3.djvu/219

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2307 of section 505 and for which pediatric studies were submitted prior to the expiration of the patent (including any patent extensions); or "(ii) a Usted patent for which a certification has been submitted under subsection (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(4)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions); or "(B) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(4)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions). " (d) CONDUCT OF PEDIATRIC STUDIES.— "(1) AGREEMENT FOR STUDIES. —The Secretary may, pursuant to a written request from the Secretary under subsection (a) or (c), after consultation with— "(A) the sponsor of an application for an investigational new drug under section 505(i); "(B) the sponsor of an application for a new drug under section 505(b)(1); or "(C) the holder of an approved application for a drug under section 505(b)(1), agree with the sponsor or holder for the conduct of pediatric studies for such drug. Such agreement shall be in writing and shall include a timeframe for such studies. " (2) WRITTEN PROTOCOLS TO MEET THE STUDIES REQUIRE- MENT.—I f the sponsor or holder and the Secretary agree upon written protocols for the studies, the studies requirement of subsection (a) or (c) is satisfied upon the completion of the studies and submission of the reports thereof in accordance with the original written request and the written agreement referred to in paragraph (1). Not later than 60 days after the submission of the report of the studies, the Secretary shall determine if such studies were or were not conducted in accordance with the original written request and the written agreement and reported in accordance with the requirements of the Secretary for filing and so notify the sponsor or holder. " (3) OTHER METHODS TO MEET THE STUDIES REQUIREMENT.— If the sponsor or holder and the Secretary have not agreed in writing on the protocols for the studies, the studies requirement of subsection (a) or (c) is satisfied when such studies have been completed and the reports accepted by the Secretary. Not later than 90 days after the submission of the reports of the studies, the Secretary shall accept or reject such reports and so notify the sponsor or holder. The Secretary's only responsibility in accepting or rejecting the reports shall be to determine, within the 90 days, whether the studies fairly respond to the written request, have been conducted in accordance with commonly accepted scientific principles and protocols, and

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