; and (C) for which the Food and Drug Administration has approved a label— (i) for disease control or prevention at the same or similar dosage level as applicable for the approved production use described in subparagraph (B); (ii) that does not specify an explicitly defined duration of therapy; or (iii) specifying a dosage that is not expected to treat a specific bacterial pathogen. (2) Review of disease prevention and control approvals (A) In general Not later than January 1, 2019, the Secretary shall initiate a process of reviewing medically important antimicrobials described in paragraph (1), in accordance with subparagraph (B). (B) Review of approval (i) In general If, not later than January 1, 2020, a sponsor of an antimicrobial drug described in paragraph (1) submits to the Secretary sufficient evidence to demonstrating that, with respect to such drug— (I) there is evidence of effectiveness in controlling or preventing bacterial disease; (II) an approved use is consistent with accepted veterinary practice; (III) an approved use targets a specific bacterial pathogen; (IV) an approved use is appropriately targeted to animals at risk of developing a specific bacterial disease; (V) an approved use has an explicitly defined duration of therapy