Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Withdrawal of Notice of Opportunity for Hearing

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The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is announcing the withdrawal of a notice of opportunity for a hearing (NOOH), which proposed to withdraw the approved uses of carbadox, a carcinogenic animal drug intended for use in feeds for swine. FDA is publishing a proposed order that, if finalized, will revoke the current approved method for carbadox because it does not satisfy the statutory requirement that there be a method to ensure that no residue of carcinogenic concern remains in the edible tissues of treated swine. If that order is finalized, we intend to publish in the Federal Register an NOOH proposing to withdraw approval of all new animal drug applications for use of carbadox.