The US Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Elanco Animal Health, A Division of Eli Lilly & Co.
The supplemental NADAs provide for administering a Type C medicated feed containing ractopamine hydrochloride as a top dress on Type C medicated feeds containing monensin, USP, or monensin, USP, and tylosin phosphate to cattle fed in confinement for slaughter.
This rule is effective September 3, 2010.
Elanco Animal Health, a division of Eli Lilly & Co. (Indianapolis, IN), filed a supplement to NADA 141-225 that provides for use of Opraflexx (ractopamine hydrochloride) and Rumensin (monensin, USP) Type A medicated articles to formulate two-way combination drug Type C medicated feeds for cattle fed in confinement for slaughter.
Elanco Animal Health also filed a supplement to NADA 141-224 including the above mentioned products and Tylan (tylosin phosphate) to formulate three-way combination drug Type C medicated feeds for cattle fed in confinement for slaughter.
The supplemental NADAs provide for administering ractopamine hydrochloride Type C medicated feeds as a top dress on Type C medicated feeds containing monensin, USP, or monensin, USP, and tylosin phosphate to cattle fed in confinement for slaughter as the means by which the two-way or three-way combinations will be created.
Supplemental NADA 141-224 is approved as of June 7, 2010; supplemental NADA 141-225 is approved as of June 17, 2010; and the regulations in 21 CFR 558.500 are amended to reflect the approvals.
In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summaries of safety and effectiveness data and information submitted to support approval of these applications may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33 that these actions are of a type that do not individually or cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental impact statement is required.
This rule does not meet the definition of "rule" in 5 U.S.C. 804(3)(A) because it is a rule of "particular applicability." Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.