CERTAINTY OF REVIEW TIMEFRAMES; COLLABORATIVE REVIEW PROCESS.

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.