[Federal Register Volume 69, Number 51 (Tuesday, March 16, 2004)]
[Rules and Regulations]
[Page 12271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5863]


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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 the 
addition of tylosin tartrate to an approved subcutaneous implant 
containing trenbolone and estradiol used for increased rate of weight 
gain and improved feed efficiency in feedlot steers.

DATES: This rule is effective March 16, 2004.

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 a 
supplement to ANADA 200-221 for COMPONENT TE-IS (trenbolone acetate and 
estradiol) with TYLAN, a subcutaneous implant used for increased rate 
of weight gain and improved feed efficiency in steers fed in 
confinement for slaughter.
    The supplemental ANADA provides for the addition of a pellet 
containing 29 milligrams tylosin tartrate to the approved implant.
    The supplemental application is approved as of February 13, 2004, 
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 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this supplemental 
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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning February 13, 
2004.
    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

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

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

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2. Section 522.2477 is amended by adding paragraph (d)(1)(i)(F) to read 
as follows:


Sec.  522.2477  Trenbolone acetate and estradiol.

* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (F) 80 mg trenbolone acetate and 16 mg estradiol (one implant 
consisting of 5 pellets, each of 4 pellets containing 20 mg trenbolone 
acetate and 4 mg estradiol, and 1 pellet containing 29 mg tylosin 
tartrate) per implant dose.
* * * * *

    Dated: March 2, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-5863 Filed 3-15-04; 8:45 am]
BILLING CODE 4160-01-S