Page:United States Statutes at Large Volume 102 Part 4.djvu/1007

 PUBLIC LAW 100-670—NOV. 16, 1988

102 STAT. 3977

drug has been withdrawn from sale for safety or effectiveness reasons; "(x) the application does not meet any other requirement of subsection (n); or "(xi) the application contains an untrue statement of material fact. "(B) If the Secretary finds that a new animal drug for which an application is submitted under subsection (b)(2) is bioequivalent to the approved new animal drug referred to in such application and that residues of the new animal drug are consistent with the tolerances established for such approved new animal drug but at a withdrawal period which is different than the withdrawal period approved for such approved new animal drug, the Secretary may establish, on the basis of information submitted, such different withdrawal period as the withdrawal period for the new animal drug for purposes of the approval of such application for such drug. "(C) Within 180 days of the initial receipt of an application under subsection (b)(2) or within such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall approve or disapprove the application. "(D) The approval of an application filed under subsection (b)(2) shall be made effective on the last applicable date determined under the following: "(i) If the applicant only made a certification described in clause (i) or (ii) of subsection (n)(l)(G) or in both such clauses, the approval may be made effective immediately. '(ii) If the applicant made a certification described in clause (iii) of subsection (n)(l)(G), the approval may be made effective on the date certified under clause (iii). "(iii) If the applicant made a certification described in clause Courts, U.S. (iv) of subsection (n)(l)(G), the approval shall be made effective imm'ediately unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of 45 days from the date the notice provided under subsection (n)(2)(B)(i) is received. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the 30 month period beginning on the date of the receipt of the notice provided under subsection (n)(2)(B) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, except that if before the expiration of such period— "(I) the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of the court decision, "(II) the court decides that such patent has been infringed, the approval shall be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, United States Code, or "(III) the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of such court decision. In such an action, each of the parties shall reasonably cooperate in expediting the action. Until the expiration of 45 days from

�