E7-23517. New Animal Drugs For Use in Animal Feeds; Monensin USP

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

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. The supplemental NADA removes the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats.

DATES:

This rule is effective December 5, 2007.

FOR FURTHER INFORMATION CONTACT:

Daniel A. Benz, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0223, 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 95-735 that provides for use of RUMENSIN 80 (monensin) Type A medicated articles. The supplement removes the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats. The supplemental NADA is approved as of November 9, 2007, and the regulations in 21 CFR 558.355 are amended to reflect the approval.

In addition, the regulations are being amended to remove a redundant entry for combination use of monensin USP and melengestrol acetate, with or without tylosin phosphate, in medicated feed for heifers fed in confinement for slaughter. This action is being taken to improve the clarity of the regulations.

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(a)(1) 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 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, remove and reserve paragraphs (d)(2), (d)(3), and (f)(3)(viii); and revise paragraph (f)(6)(i)( b)(1) to read as follows:

§ 558.355

Monensin.

* * * * *

(f) * * *

(6) * * *

(i) * * *

(b) * * *

(1) Feed continuously. Feed only to goats being fed in confinement. Do not feed to lactating goats. Type C feeds may be manufactured from monensin liquid Type B feeds. The liquid Type B feeds have a pH of 4.3 to 7.1 and their labels must bear appropriate mixing directions, as defined in paragraph (d)(12) of this section. See special labeling considerations in paragraph (d) of this section.

* * * * *

Dated: November 20, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.