[Federal Register Volume 69, Number 226 (Wednesday, November 24, 2004)]
[Rules and Regulations]
[Page 68253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25978]


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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 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 two supplemental new animal 
drug applications (NADAs) filed by Intervet Inc.; three supplemental 
abbreviated new animal drug applications (ANADAs) filed by Ivy 
Laboratories, Division of Ivy Animal Health, Inc.; and a supplemental 
ANADA filed by Fort Dodge Animal Health, Division of Wyeth. The 
supplemental NADAs and ANADAs provide for the addition of statements to 
labeling of subcutaneous implants containing trenbolone acetate and 
estradiol warning against the use of these products in calves to be 
processed for veal.

DATES: This rule is effective November 24, 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 supplements to NADA 140-897 and NADA 
140-992 for REVALOR (trenbolone acetate and estradiol) implants. Ivy 
Laboratories, Division of Ivy Animal Health, Inc., 8857 Bond St., 
Overland Park, KS 66214, filed supplements to ANADA 200-221 and ANADA 
200-346 for COMPONENT (trenbolone acetate and estradiol) and COMPONENT 
plus TYLAN (trenbolone acetate and estradiol with tylosin tartrate) 
implants. Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. 
NW., Fort Dodge, IA 50501, filed a supplement to ANADA 200-367 for 
SYNOVEX (trenbolone acetate and estradiol) implants. The supplemental 
NADAs and ANADAs 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 28, 
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 21 CFR 514.11(e)(2)(ii), summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications 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 
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.

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2. Section 522.2477 is amended by revising paragraphs (d)(1)(iii), 
(d)(2)(iii), and (d)(3)(iii) to read as follows:


Sec.  522.2477  Trenbolone acetate and estradiol.

* * * * *
    (d) * * *
    (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.
    (3) * * *
    (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 10, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-25978 Filed 11-23-04; 8:45 am]
BILLING CODE 4160-01-S