Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA revises limitations for liquid Type B medicated cattle feeds containing tylosin phosphate.
This rule is effective October 15, 2009.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 12-491 for use of TYLAN (tylosin phosphate) Type A medicated article. For liquid Type B medicated cattle feeds containing tylosin phosphate, the supplement removes the presolubilization instructions previously required for manufacture and reduces the expiry from 8 weeks to 31 days. The supplemental NADA is approved as of September 8, 2009, and the regulations in 21 CFR 558.625 are amended to reflect the approval. In addition, the limitations for two-way combination drug medicated liquid feeds containing tylosin and monensin in 21 CFR 558.355 are amended to reflect the revised limitations for tylosin liquid feeds.
Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.
The agency has determined under 21 CFR 25.33 that this action is of a type that does 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.Start List of Subjects
List of Subjects in 21 CFR Part 558End List of Subjects Start Amendment Part
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine,End Amendment Part Start Part
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. In § 558.355, revise paragraph (f)(3)(ii)(End Amendment Part
(f) * * *
(3) * * *
(ii) * * *
(b) Limitations. Feed only to cattle being fed in confinement for slaughter. Feed continuously as sole ration at the rate of 50 to 480 milligrams of monensin and 60 to 90 milligrams of tylosin per head per day. Combination drug liquid Type B medicated feeds may be used to manufacture dry Type C medicated feeds as in § 558.625(c) of this chapter.
3. In § 558.625, remove and reserve paragraph (c)(2)(i); and in paragraph (c)(3), remove “8 weeks” and in its place add “31 days”.End Amendment Part Start Signature
Dated: September 25, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. E9-24716 Filed 10-14-09; 8:45 am]
BILLING CODE 4160-01-S