PETITIONS FOR CLAIMS.

SEC. 302. PETITIONS FOR CLAIMS. Section 403(r)(4)(A)(i) (21 U.S.C. 343(r)(4)(A)(i)) is amended— (1) by adding after the second sentence the following: “If the Secretary does not act within such 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner.”; (2) in the fourth sentence (as amended by paragraph (1)) by inserting immediately before the comma the following: “or the petition is deemed to be denied”; and (3) by adding at the end the following: “If the Secretary does not act within such 90 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by the Secretary and the petitioner. If the Secretary issues a proposed regulation, the rulemaking shall be completed within 540 days of the date the petition is received by the Secretary. If the Secretary does not issue a regulation within such 540 days, the Secretary shall provide the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate the reasons action on the regulation did not occur within such 540 days.”.