; (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; and (VI) there is not a reasonable probability of risk to the public health due to the development of antimicrobial resistance, the Secretary, not later than December 31, 2020, shall issue a revised label approval for such antimicrobial drug, as necessary. (ii) Insufficient evidence If the sponsor of an antimicrobial drug described in paragraph (1) does not submit sufficient evidence as described in clause (i) by December 31, 2020, the Secretary shall withdraw approval of any indication claims described in paragraph (1)(B) for which the sponsor does not submit evidence or for which the Secretary determines the evidence submitted is insufficient and, as necessary, issue a revised label approval. (C) Withdrawal of claims On or before January 1, 2020, the sponsor of a drug described in paragraph (1) may request the approval of the Secretary to remove any label claim described in paragraph (1)(B), and the Secretary shall approve any such request and, as necessary, issue a revised label. The sponsor shall not be required to submit the evidence required under subparagraph (B)(i) with respect to any claim so withdrawn. (3) Exemptions In the case of a drug that is a medically important antimicrobial for which the Secretary grants an exemption under section 505(i), the withdrawal of indication claims in a food-producing animal in accordance with paragraph (2)(B) shall be effective on the date that is 2 years after the date on which the Secretary grants the exemption, unless, not later than 2 years after the date on which the Secretary grants the exemption, the Secretary provides a written determination of intent to extend the exemption. (4) Definition (A) In general In this subsection, the term medically important antimicrobial means a drug that— (i) is intended for use in food-producing animals