FINAL AGENCY ACTION RELATING TO PETITIONS AND CIVIL ACTIONS.

SEC. 1135. FINAL AGENCY ACTION RELATING TO PETITIONS AND CIVIL ACTIONS. Section 505(q) (21 U.S.C. 355(q)) is amended— (1) in paragraph (1)— (A) in subparagraph (A), by striking “subsection (b)(2) or (j)” and inserting “subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act”; and (B) in subparagraph (F), by striking “180 days” and inserting “150 days”; (2) in paragraph (2)(A)— (A) in the subparagraph heading, by striking “180” and inserting “150”; and (B) in clause (i), by striking “180-day” and inserting “150-day”; (3) in paragraph (4)— (A) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and moving such clauses, as so redesignated, 2 ems to the right; (B) by striking “This subsection does not apply to—” and inserting the following: “(A) This subsection does not apply to—” ; and (C) by adding at the end the following: “(B) Paragraph (2) does not apply to a petition addressing issues concerning an application submitted pursuant to section 351(k) of the Public Health Service Act.” ; and (4) in paragraph (5), by striking “subsection (b)(2) or (j)” inserting “subsection (b)(2) or (j) of the Act or 351(k) of the Public Health Service Act”.