[Federal Register Volume 68, Number 184 (Tuesday, September 23, 2003)]
[Rules and Regulations]
[Pages 55200-55201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24157]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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 heifers for increased rate of weight gain.

DATES: This rule is effective September 23, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal 
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a 
supplement to ANADA 200-346. The supplemental ANADA provides for the 
use of COMPONENT TE-IH (trenbolone acetate and estradiol), a 
subcutaneous implant containing 80 milligrams (mg) trenbolone acetate 
and 8 mg estradiol in heifers fed in confinement for slaughter for 
increased rate of weight gain. Ivy Laboratories' COMPONENT TE-IH is 
approved as a generic copy of Intervet, Inc.'s REVALOR-IH, approved 
under NADA 140-992. The application is approved as of August 19, 2003, 
and the regulations are amended in 21 CFR 522.2477 to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.
    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.

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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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

[[Page 55201]]

Sec.  522.2477  [Amended]

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2. Section 522.2477 Trenbolone acetate and estradiol is amended in 
paragraph (b)(1) by removing ``(d)(2)(ii)(A),'' and by adding in its 
place ``(d)(2)(i)(C),''.

    Dated: September 15, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-24157 Filed 9-22-03; 8:45 am]
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