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[Federal Register Volume 69, Number 224 (Monday, November 22, 2004)]
[Rules and Regulations]
[Pages 67817-67818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25878]

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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 Benzoate

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) filed by Fort Dodge Animal Health, Division of 
Wyeth. The supplemental NADA provides for the addition of statements to 
labeling of subcutaneous implants containing trenbolone acetate and 
estradiol benzoate warning against the use of these products in calves 
to be processed for veal.

DATES: This rule is effective November 22, 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: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 
141-043 for SYNOVEX PLUS (trenbolone acetate and estradiol benzoate) 
and SYNOVEX CHOICE (trenbolone acetate and estradiol benzoate), two 
subcutaneous implants products used in steers and heifers fed in 
confinement for slaughter for increased rate of weight gain and/or 
improved feed efficiency. The supplemental NADA provides for the 
addition of statements to labeling warning against the use of these 
products in calves to be processed for veal. The supplemental 
application is approved as of October 28, 2004, and the regulations are 
amended in 21 CFR 522.2478 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

[[Page 67818]]

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.

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 522.2478 is amended by revising paragraphs (d)(1)(i)(C), 
(d)(1)(ii)(C), and (d)(2)(iii) to read as follows:

Sec.  522.2478  Trenbolone acetate and estradiol benzoate.

* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (C) Limitations. Implant subcutaneously in ear only. 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.
    (ii) * * *
    (C) Limitations. Implant subcutaneously in ear only. 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. Not for 
subsequent breeding dairy or beef replacement heifers. 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. 04-25878 Filed 11-19-04; 8:45 am]
BILLING CODE 4160-01-S
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