Page:United States Statutes at Large Volume 102 Part 4.djvu/1009

 PUBLIC LAW 100-670—NOV. 16, 1988

102 STAT. 3979

food safety studies (other than bioequivalence or residue studies) essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under subsection (b)(2) for the conditions of approval of such drug in the subsection (b)(l) application effective before the expiration of 3 years from the date of the approval of the application under subsection (b)(1) for such drug. "(iii) If a supplement to an application approved under subsection 03X1) is approved after the date of enactment of this paragraph and the supplement contains reports of new clinical or field investigations (other than bioequivalence or residue studies) and, in the case of food producing animals, human food safety studies (other than bioequivalence or residue studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the supplement, the Secretary may not make the approval of an application submitted under subsection OoX2) for a change approved in the supplement effective before the expiration of 3 years from the date of the approval of the supplement. "(iv) An applicant under subsection (b)(l) who comes within the provisions of clause (i) of this subparagraph as a result of an application which seeks approval for a use solely in non-food producing animals, may elect, within 10 days of receiving such approval, to waive clause (i) of this subparagraph, in which event the limitation on approval of applications submitted under subsection (b)(2) set forth in clause (ii) of this subparagraph shall be applicable to the subsection (b)(l) application. "(v) If an application (including any supplement to a new animal drug application) submitted under subsection (b)(1) for a new animal drug for a food-producing animal use, which includes an active ingredient (including any ester or salt of the active ingredient) which has been the subject of a waiver under subparagraph (B)(iv) is approved after the date of enactment of this paragraph, and if the application contains reports of clinical or field investigations or human food safety studies (other than bioequivalence or residue studies) essential to the new approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application (including any supplement to such application) submitted under subsection (b)(2) for the new conditions of approval of such drug in the subsection (b)(1) application effective before the expiration of five years from the date of approval of the application under subsection 0)X1) for such drug. The provisions of this paragraph shall apply only to the first approval for a foodproducing animal use for the same applicant after the waiver under subparagraph (B)(iv). "(G) If an approved application submitted under subsection (b)(2) for a new animal drug refers to a drug the approval of which was withdrawn or suspended for grounds described in paragraph (1) or (2) of subsection (e) or WEIS withdrawn or suspended under this subparagraph or which, as determined by the Secretary, has been withdrawn from sale for safety or effectiveness reasons, the approval of the drug under this paragraph shall be withdrawn or suspended— under subsection (e) or this subparagraph, or "(ii) if the approved new animal drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier,
 * (i) for the same period as the withdrawal or suspension

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