New Animal Drugs; Removal of Obsolete and Redundant Regulations

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The Food and Drug Administration (FDA) is proposing removal of regulations that exempted certain new animal drugs administered in feed from batch certification requirements. FDA is also proposing removal of regulations that required sponsors to submit data regarding the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed. The intended effect of this proposed rule is to remove regulations that are obsolete or redundant. Some of the products and combination uses subject to the listings in these regulations are subject to a notice of findings of effectiveness and an opportunity for hearing published elsewhere in this issue of the Federal Register. One approved product subject to the regulations proposed for removal is being codified elsewhere in this issue of the Federal Register.