[Federal Register Volume 72, Number 64 (Wednesday, April 4, 2007)]
[Rules and Regulations]
[Pages 16270-16271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Melengestrol and 
Lasalocid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 16271]]

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 single-ingredient 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.

DATES: This rule is effective April 4, 2007.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Div. of Ivy Animal Health, 
Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-451 for 
use of HEIFERMAX 500 (melengestrol acetate) Liquid Premix and BOVATEC 
(lasalocid sodium) single-ingredient Type A medicated articles to make 
dry and liquid, two-way combination drug Type B or Type C medicated 
feeds for heifers fed in confinement for slaughter. Ivy Laboratories' 
ANADA 200-451 is approved as a generic copy of NADA 140-288, 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 
(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(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. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

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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.


Sec.  558.342   [Amended]

0
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. E7-6180 Filed 4-3-07; 8:45 am]
BILLING CODE 4160-01-S