Page:United States Statutes at Large Volume 121.djvu/975

 121 STAT. 954

‘‘(1) IN GENERAL.— ‘‘(A) DETERMINATION.—The Secretary shall not delay approval of a pending application submitted under subsection (b)(2) or (j) because of any request to take any form of action relating to the application, either before or during consideration of the request, unless— ‘‘(i) the request is in writing and is a petition submitted to the Secretary pursuant to section 10.30 or 10.35 of title 21, Code of Federal Regulations (or any successor regulations); and ‘‘(ii) the Secretary determines, upon reviewing the petition, that a delay is necessary to protect the public health. ‘‘(B) NOTIFICATION.—If the Secretary determines under subparagraph (A) that a delay is necessary with respect to an application, the Secretary shall provide to the applicant, not later than 30 days after making such determination, the following information: ‘‘(i) Notification of the fact that a determination under subparagraph (A) has been made. ‘‘(ii) If applicable, any clarification or additional data that the applicant should submit to the docket on the petition to allow the Secretary to review the petition promptly. ‘‘(iii) A brief summary of the specific substantive issues raised in the petition which form the basis of the determination. ‘‘(C) FORMAT.—The information described in subparagraph (B) shall be conveyed via either, at the discretion of the Secretary— ‘‘(i) a document; or ‘‘(ii) a meeting with the applicant involved. ‘‘(D) PUBLIC DISCLOSURE.—Any information conveyed by the Secretary under subparagraph (C) shall be considered part of the application and shall be subject to the disclosure requirements applicable to information in such application. ‘‘(E) DENIAL BASED ON INTENT TO DELAY.—If the Secretary determines that a petition or a supplement to the petition was submitted with the primary purpose of delaying the approval of an application and the petition does not on its face raise valid scientific or regulatory issues, the Secretary may deny the petition at any point based on such determination. The Secretary may issue guidance to describe the factors that will be used to determine under this subparagraph whether a petition is submitted with the primary purpose of delaying the approval of an application. ‘‘(F) FINAL AGENCY ACTION.—The Secretary shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted. The Secretary shall not extend such period for any reason, including— ‘‘(i) any determination made under subparagraph (A);

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