; (C) by striking subparagraph (F); (D) by redesignating subparagraphs (G) through (I) as subparagraphs (F) through (H), respectively; and (E) in subparagraph (H), as so redesignated, by striking submission of this petition and inserting submission of this document ; (2) in paragraph (2)— (A) by redesignating subparagraphs (A) through (C) as subparagraphs (C) through (E), respectively; (B) by inserting before subparagraph (C), as so redesignated, the following: (A) In general A person shall submit a petition to the Secretary under paragraph (1) before filing a civil action in which the person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act. Such petition and any supplement to such a petition shall describe all information and arguments that form the basis of the relief requested in any civil action described in the previous sentence. (B) Timely submission of citizen petition A petition and any supplement to a petition shall be submitted within 180 days after the person knew the information that forms the basis of the request made in the petition or supplement. ; (C) in subparagraph (C), as so redesignated— (i) in the heading, by striking within 150 days ; (ii) in clause (i), by striking during the 150-day period referred to in paragraph (1)(F), ; and (iii) by amending clause (ii) to read as follows: (ii) on or after the date that is 151 days after the date of submission of the petition, the Secretary approves or has approved the application that is the subject of the petition without having made such a final decision.