Page:United States Statutes at Large Volume 111 Part 3.djvu/253

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2341 "(ii) the opportunity to submit, for review by a classification panel, information that is based on the data or information provided in the application submitted under section 515 by the person, which information shall be submitted to the Secretary for prompt transmittal to the classification panel; and "(iii) the same opportunity as the Secretary to participate in meetings of the panel. "(B) Any meetings of a classification panel shall provide adequate time for initial presentations and for response to any differing views by persons whose devices are specifically the subject of a classification panel review, and shall encourage free and open participation by all interested persons. "(7) After receiving from a classification panel the conclusions and recommendations of the panel on a matter that the panel has reviewed, the Secretary shall review the conclusions and recommendations, shall make a final decision on the matter in accordance with section 515(d)(2), and shall notify the affected persons of the decision in writing and, if the decision differs from the conclusions and recommendations of the panel, shall include the reasons for the difference. "(8) A classification panel under this subsection shall not be subject to the annual chartering and annual report requirements of the Federal Advisory Committee Act.". SEC. 209. CERTAINTY OF REVIEW TIMEFRAMES; COLLABORATIVE REVIEW PROCESS. (a) CERTAINTY OF REVIEW TIMEFRAMES.— Section 510 (21 U.S.C. 360), as amended by section 206(a)(2), is amended by adding at the end the following subsection: "(n) The Secretary shall review the report required in subsection (k) and make a determination under section 513(f)(1) not later than 90 days after receiving the report.". (b) COLLABORATIVE REVIEW PROCESS. —Section 515(d) (21 U.S.C. 360e(d)), as amended by section 202(1), is amended by inserting after paragraph (2) the following: "(3)(A)(i) The Secretary shall, upon the written request of an applicant, meet with the applicant, not later than 100 days after the receipt of an application that has been filed as complete under subsection (c), to discuss the review status of the application. "(ii) The Secretary shall, in writing and prior to the meeting, provide to the applicant a description of any deficiencies in the application that, at that point, have been identified by the Secretary based on an interim review of the entire application and identify the information that is required to correct those deficiencies. "(iii) The Secretary shall notify the applicant promptly of— "(I) any additional deficiency identified in the application, or "(II) any additional information required to achieve completion of the review and final action on the application, that was not described as a deficiency in the written description provided by the Secretary under clause (ii). "(B) The Secretary and the applicant may, by mutual consent, establish a different schedule for a meeting required under this paragraph.

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