[Federal Register Volume 68, Number 158 (Friday, August 15, 2003)]
[Rules and Regulations]
[Pages 48784-48785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20797]


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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 steers for increased rate of weight gain and improved feed 
efficiency.

DATES: This rule is effective August 15, 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-200 (trenbolone acetate and estradiol), a 
subcutaneous implant containing 200 milligrams (mg) trenbolone acetate 
and 20 mg estradiol in steers fed in confinement for slaughter for 
increased rate of weight gain and improved feed efficiency. Ivy 
Laboratories' COMPONENT TE-200 is approved as a generic copy of 
Intervet, Inc.'s REVALOR-200, approved under NADA 140-992. The 
application is approved as of April 21, 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 Dockets Management Branch (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 48785]]

Sec.  522.2477  [Amended]

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2. Section 522.2477 Trenbolone acetate and estradiol is amended in 
paragraph (b)(1) by adding ``(d)(1)(i)(C),'' after ``(d)(1)(i)(B),''.

    Dated: August 1, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-20797 Filed 8-14-03; 8:45 am]
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