E9-24716. New Animal Drugs for Use in Animal Feeds; Monensin; Tylosin

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

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.

DATES:

This rule is effective October 15, 2009.

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: [e-mail].

SUPPLEMENTARY 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.

List of Subjects in 21 CFR Part 558

• Animal drugs
• Animal feeds

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, 21 CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

2. In § 558.355, revise paragraph (f)(3)(ii)( b) to read as follows:

§ 558.355

Monensin.

(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.

§ 558.625

[Amended]

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”.

Dated: September 25, 2009.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.