Page:United States Statutes at Large Volume 102 Part 4.djvu/1002

 102 STAT. 3972

PUBLIC LAW 100-670—NOV. 16, 1988 drug listed under paragraph (4) (hereinafter in this subsection referred to as an 'approved new animal drug'), and "(ii) information to show that the withdrawal period at which residues of the new animal drug will be consistent with the tolerances established for the approved new animal drug is the same as the withdrawal period previously established for the approved new animal drug or, if the withdrawal period is proposed to be different, information showing that the residues of the new animal drug at the proposed different withdrawal period will be consistent with the tolerances established for the approved new animal drug; "(B)(i) information to show that the active ingredients of the new animal drug are the same as those of the approved new animal drug, and "(ii) if the approved new animal drug has more than one active ingredient, and if one of the active ingredients of the new animal drug is different from one of the active ingredients of the approved new animal drug and the application is filed pursuant to the approval of a petition filed under paragraph (3)"(I) information to show that the other active ingredients of the new animal drug are the same as the active ingredients of the approved new animal drug, "(II) information to show either that the different active ingredient is an active ingredient of another approved new animal drug or of an animal drug which does not meet the requirements of section 201(w), and "(III) such other information respecting the different active ingredients as the Secretary may require; "(C)(i) if the approved new animal drug is permitted to be used with one or more animal drugs in animal feed, information to show that the proposed uses of the new animal drug with other animal drugs in animal feed are the same as the uses of the approved new animal drug, and "(ii) if the approved new animal drug is permitted to be used with one or more other animal drugs in animal feed, and one of the other animal drugs proposed for use with the new animal drug in animal feed is (hfferent from one of the other animal drugs permitted to be used in animal feed with the approved new animal drug, and the application is filed pursuant to the approval of a petition filed under paragraph (3)— "(I) information to show either that the different animal drug proposed for use with the approved new animal drug in anim£d feed is an approved new animal drug permitted to be used in animal feed or does not meet the requirements of section 201(w) when used with another animal drug in animal feed, "(II) information to show that other animal drugs proposed for use with the new animal drug in animal feed are the same as the other animal drugs permitted to be used with the approved new animal drug, and "(III) such other information respecting the different animal drug or combination with respect to which the petition was filed as the Secretary may require, "(D) information to show that the route of administration, the dosage form, and the strength of the new animal drug are the same as those of the approved new animal drug or, if the route

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