New Animal Drugs for Use in Animal Feeds:

Federal Register Volume 76, Number 203 (Thursday, October 20, 2011)

Rules and Regulations

Pages 65109-65110

From the Federal Register Online via the Government Printing Office [www.gpo.gov]

FR Doc No: 2011-27139

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 558

Docket No. FDA-2011-N-0003

New Animal Drugs for Use in Animal Feeds; Melengestrol; 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 abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of

Ivy Animal Health, Inc. The supplemental ANADA provides for use of increased dose levels of monensin in three-way, combination drug Type C medicated feeds for heifers fed in confinement for slaughter containing melengestrol acetate, monensin, and tylosin.

DATES: This rule is effective October 20, 2011.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for

Veterinary Medicine (HFV-170), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal

Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a supplement to ANADA 200-375 for use of HEIFERMAX 500 (melengestrol acetate), RUMENSIN (monensin, USP), and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles to make three-way, combination drug Type C medicated feeds for heifers fed in confinement for slaughter. The supplemental ANADA provides for use of increased dose levels of monensin. The supplemental application is approved as of

September 1, 2011, and the regulations in 21 CFR 558.342 are amended to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application 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 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 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 0 1. The authority citation for 21 CFR part 558 continues to read as follows:

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

Page 65110

Sec. 558.342 [Amended] 0 2. In Sec. 558.342, in the table in paragraph (e)(1), remove and reserve paragraph (e)(1)(vii); and in paragraph (e)(1)(xi), in the

``Sponsor'' column, add ``021641''.

Dated: October 14, 2011.

Steven D. Vaughn,

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

Medicine.

FR Doc. 2011-27139 Filed 10-19-11; 8:45 am

BILLING CODE 4160-01-P