Case 1:16-cv-01350-RBW Document 34 Filed 02/03/17 Page 49 of 61 37 The foregoing statutory provisions are fully consistent with others that expressly require a hearing in connection with restrictions upon, or withdrawal of, drug approvals — even for the most serious regulatory compliance concerns. See 21 U.S.C. § 335c(a)(1), 335c(b) (hearing required before withdrawing ANDA approval on the ground that it was “obtained, expedited, or otherwise facilitated through bribery, payment of an illegal gratuity, or fraud or material false statement”); 21 U.S.C. § 355(e) (hearing required in connection with suspension of drug approval on the ground that there is an “imminent hazard to the public health”); 21 U.S.C. § 360b(e) (hearing required in connection with suspension of animal drug approval on the ground that there is an “imminent hazard to the health of man or of the animals for which such drug is intended”). 3.

- consult the Green Book and include in its abbreviated new animal drug application (“ANADA”) a certification regarding any listed patent on which it is basing its ANADA (indicating whether the patent is still in effect or expired). See, e.g., 21 U.S.C. § 360b(n)(1)(H). In Merial’s case, the Green Book explicitly disclosed the expiration date of the ‘569 Patent when the patent issued, and it tracked all changes in the patent’s expiration date as the law changed and as patent owner Merck sought various patent term extensions for the patent.