[Federal Register Volume 69, Number 231 (Thursday, December 2, 2004)]
[Rules and Regulations]
[Pages 70055-70056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26552]


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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 Acetate

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 new animal drug 
application (NADA) and an abbreviated supplemental new animal drug 
application (ANADA) filed by Intervet, Inc., and Ivy Laboratories, 
Division of Ivy Animal Health, Inc., respectively. The supplemental 
NADA and ANADA provide for the addition of statements to labeling of 
subcutaneous implants containing trenbolone acetate warning against the 
use of these products in calves to be processed for veal.

DATES: This rule is effective December 2 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: Intervet, Inc., 29160 Intervet Lane, P.O. 
Box 318, Millsboro, DE 19966, filed a supplement to NADA 138-612 for 
FINAPLIX-H (trenbolone acetate). Ivy Laboratories, Division of Ivy 
Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a 
supplement to ANADA 200-224 for COMPONENT T-H and COMPONENT T-S 
(trenbolone acetate), COMPONENT T-H with TYLAN and COMPONENT T-S with 
TYLAN (trenbolone acetate with tylosin tartrate). The supplemental NADA 
and ANADA provide for the addition of statements to labeling warning 
against the use of these products in calves to be processed for veal. 
The supplemental applications are approved as of October 22, 2004, and 
the regulations are amended in 21 CFR 522.2476 to reflect the approval 
and a current format. 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), summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications

[[Page 70056]]

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 these 
actions are of a type that do 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 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

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

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

0
2. Section 522.2476 is amended by removing paragraph (a); by 
redesignating paragraphs (b), (c), and (d) as paragraphs (a), (b), and 
(c); and by revising newly redesignated paragraphs (a)(1), (a)(2), 
(c)(1)(iii), and (c)(2)(iii) to read as follows:


Sec.  522.2476  Trenbolone acetate.

    (a) * * *
    (1) No. 021641 for use as in paragraph (c) of this section.
    (2) No. 057926 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii), 
(c)(1)(iii), (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of this section.
* * * * *
    (c) * * *
    (1) * * *
    (iii) Limitations. Implant subcutaneously in ear only. Do not use 
in animals intended for subsequent breeding or in dairy animals. Safety 
and effectiveness have not been established in veal calves. A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.
    (2) * * *
    (iii) Limitations. Implant subcutaneously in ear only. Do not use 
in animals intended for subsequent breeding or in dairy animals. Safety 
and effectiveness have not been established in veal calves. A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.

    Dated: November 18, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-26552 Filed 12-1-04; 8:45 am]
BILLING CODE 4160-01-S