Page:United States Statutes at Large Volume 111 Part 3.djvu/272

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Ill STAT. 2360 PUBLIC LAW 105-115—NOV. 21, 1997 "(i) a proposed protocol and schedule for conducting the studies needed for the submission of a supplemental application for the new use; and "(ii) a certification that the supplemental application will be submitted to the Secretary not later than 36 months after the date of the initial dissemination of information under section 551 (or, as applicable, not later than such date as the Secretary may specify pursuant to an extension under paragraph (3)); and "(B) the Secretary has determined that the proposed protocol is adequate and that the schedule for completing such studies is reasonable. "(2) PROGRESS REPORTS ON STUDIES.— A manufacturer that submits to the Secretary an application under paragraph (1) shall submit to the Secretary periodic reports describing the status of the studies involved. "(3) EXTENSION OF TIME REGARDING PLANNED STUDIES.— The period of 36 months authorized in paragraph (l)(A)(ii) for the completion of studies may be extended by the Secretary if— "(A) the Secretary determines that the studies needed to submit such an application cannot be completed and submitted within 36 months; or "(B) the manufacturer involved submits to the Secretary a written request for the extension and the Secretary determines that the manufacturer has acted with due diligence to conduct the studies in a timely manner, except that an extension under this subparagraph may not be provided for more than 24 additional months. " (d) EXEMPTION FROM REQUIREMENT OF SUPPLEMENTAL APPLICATION.— "(1) IN GENERAL.— For purposes of subsection (a)(2), a manufacturer may disseminate information on a new use if— "(A) the manufacturer has submitted to the Secretary an application for an exemption from meeting the requirement of subsection (a)(1); and "(B)(i) the Secretary has approved the application in accordance with paragraph (2); or "(ii) the application is deemed under paragraph (3)(A) to have been approved (unless such approval is terminated pursuant to paragraph (3)(B)). "(2) CONDITIONS FOR APPROVAL.— The Secretary may approve an application under paragraph (1) for an exemption if the Secretary makes a determination described in subparagraph (A) or (B), as follows: "(A) The Secretary makes a determination that, for reasons defined by the Secretary, it would be economically prohibitive with respect to such drug or device for the manufacturer to incur the costs necessary for the submission of a supplemental application. In making such determination, the Secretary shall consider (in addition to any other considerations the Secretary finds appropriate)— "(i) the lack of the availability under law of any period during which the manufacturer would have exclusive marketing rights with respect to the new use involved; and