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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Melengestrol and Lasalocid

DATES: This rule is effective April 4, 2007.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The ANADA provides for use of singleingredient Type A medicated articles containing melengestrol and lasalocid to make two way combination drug Type B or Type C medicated feeds for heifers fed in confinement for slaughter.

SUMMARY: Melengestrol and lasalocid,

DOCUMENT BODY: [[Page 16271]]

SUPPLEMENTAL INFORMATION

Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200451 for use of HEIFERMAX 500 (melengestrol acetate) Liquid Premix and BOVATEC (lasalocid sodium) singleingredient Type A medicated articles to make dry and liquid, twoway combination drug Type B or Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories' ANADA 200451 is approved as a generic copy of NADA 140288, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., for combination use of MGA 500 and BOVATEC. The application is approved as of March 12, 2007, and the regulations are amended in 21 CFR 558.342 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 (HFA305), 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(a)(2) 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. 801808.
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 558NEW 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.
Sec. 558.342 [Amended]
2. In Sec. 558.342, amend the table in paragraph (e)(1)(iii) in the ``Sponsor'' column by adding in numerical sequence ``021641''.

Dated: March 26, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E76180 Filed 4307; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT John K. Harshman, Center for Veterinary Medicine (HFV104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018270169, email:
john.harshman@fda.hhs.gov.