[Federal Register Volume 68, Number 184 (Tuesday, September 23, 2003)]
[Rules and Regulations]
[Pages 55199-55200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24161]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Trenbolone and Estradiol; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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 an 
additional dose of trenbolone acetate and estradiol implant for use in 
feedlot steers for increased rate of weight gain and improved feed 
efficiency. This section of the regulations is also being amended to 
remove a redundant description of another strength implant. This action 
is being taken to improve the accuracy of the regulations.

DATES: This rule is effective September 23, 2003.

[[Page 55200]]


FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal 
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed 
supplemental ANADA 200-221 for COMPONENT TE-IS (trenbolone acetate/
estradiol), a subcutaneous ear implant containing 80 milligrams (mg) 
trenbolone acetate and 16 mg estradiol, in four pellets, each pellet 
containing 20 mg of trenbolone acetate and 4 mg of estradiol. The 
implants are used in steers fed in confinement for slaughter for 
increased rate of weight gain and improved feed efficiency. Ivy 
Laboratories' COMPONENT TE-IS is approved as a generic copy of 
Intervet, Inc.'s REVALOR-IS, approved under NADA 140-897. The 
supplemental application is approved as of September 3, 2003, and 21 
CFR 522.2477 is amended to reflect the approval. The basis of approval 
is discussed in the freedom of information summary.
    In addition, Sec.  522.2477 is being amended to remove a redundant 
description of another strength implant. This action is being taken to 
improve the accuracy of the regulations.
    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)(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 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 522

    Animal drugs.

0
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 522 is 
amended as follows:

PART 522-IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Section 522.2477 is amended in paragraph (b)(1) by removing 
``(d)(1)(i)(A), (d)(1)(i)(B), (d)(1)(i)(C), (d)(1)(ii)'' and by adding 
in its place ``(d)(1)''; and by revising paragraph (d)(1)(i)(D) to read 
as follows:


Sec.  522.2477  Trenbolone acetate and estradiol.

* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (D) 80 mg trenbolone acetate and 16 mg estradiol (one implant 
consisting of 4 pellets, each pellet containing 20 mg trenbolone 
acetate and 4 mg estradiol) per implant dose.
* * * * *

    Dated: September 15, 2003.
Steven D. Vaugh,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-24161 Filed 9-22-03; 8:45 am]
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