121 STAT. 956
to the party and the names of such persons or organizations inserted in the first and second blank space, respectively. ‘‘(2) EXHAUSTION OF ADMINISTRATIVE REMEDIES.— ‘‘(A) FINAL AGENCY ACTION WITHIN 180 DAYS.—The Secretary shall be considered to have taken final agency action on a petition if— ‘‘(i) during the 180-day period referred to in paragraph (1)(F), the Secretary makes a final decision within the meaning of section 10.45(d) of title 21, Code of Federal Regulations (or any successor regulation); or ‘‘(ii) such period expires without the Secretary having made such a final decision. ‘‘(B) DISMISSAL OF CERTAIN CIVIL ACTIONS.—If a civil action is filed against the Secretary with respect to any issue raised in the petition before the Secretary has taken final agency action on the petition within the meaning of subparagraph (A), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies. ‘‘(C) ADMINISTRATIVE RECORD.—For purposes of judicial review related to the approval of an application for which a petition under paragraph (1) was submitted, the administrative record regarding any issue raised by the petition shall include— ‘‘(i) the petition filed under paragraph (1) and any supplements and comments thereto; ‘‘(ii) the Secretary’s response to such petition, if issued; and ‘‘(iii) other information, as designated by the Secretary, related to the Secretary’s determinations regarding the issues raised in such petition, as long as the information was considered by the agency no later than the date of final agency action as defined under subparagraph (2)(A), and regardless of whether the Secretary responded to the petition at or before the approval of the application at issue in the petition. ‘‘(3) ANNUAL REPORT ON DELAYS IN APPROVALS PER PETITIONS.—The Secretary shall annually submit to the Congress a report that specifies— ‘‘(A) the number of applications that were approved during the preceding 12-month period; ‘‘(B) the number of such applications whose effective dates were delayed by petitions referred to in paragraph (1) during such period; ‘‘(C) the number of days by which such applications were so delayed; and ‘‘(D) the number of such petitions that were submitted during such period. ‘‘(4) EXCEPTIONS.—This subsection does not apply to— ‘‘(A) a petition that relates solely to the timing of the approval of an application pursuant to subsection (j)(5)(B)(iv); or ‘‘(B) a petition that is made by the sponsor of an application and that seeks only to have the Secretary take or refrain from taking any form of action with respect to that application.
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