[Federal Register Volume 69, Number 226 (Wednesday, November 24, 2004)]
[Rules and Regulations]
[Pages 68252-68253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25977]


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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; 
Estradiol Benzoate and Testosterone Propionate

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 supplemental new animal drug 
applications (NADAs) filed by Fort Dodge Animal Health, Division of 
Wyeth, and Ivy Laboratories, Division of Ivy Animal Health, Inc. The 
supplemental NADAs provide for the addition of statements to labeling 
of subcutaneous implants containing estradiol benzoate and testosterone 
propionate 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: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 
011-427 for SYNOVEX H (estradiol benzoate and testosterone propionate). 
Ivy Laboratories, Division of Ivy Animal Health, Inc., 8857 Bond St., 
Overland Park, KS 66214, filed a supplement to NADA 135-906 for 
COMPONENT E-H (estradiol benzoate and testosterone propionate) and 
COMPONENT E-H with TYLAN (estradiol benzoate and testosterone 
propionate with tylosin tartrate). The supplemental NADAs 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 18, 2004, and the regulations 
are amended in 21 CFR 522.842 to reflect the approvals and a current 
format. The basis of approval is discussed in the freedom of 
information summaries.
    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 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 522.842 is revised to read as follows:

[[Page 68253]]

Sec.  522.842  Estradiol benzoate and testosterone propionate.

    (a) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (c) of this section.
    (1) No. 000856 for use as in paragraph (c)(1)(i), (c)(2), and 
(c)(3) of this section.
    (2) No. 021641 for use as in paragraph (c) of this section.
    (b) Related tolerances. See Sec. Sec.  556.240 and 556.710 of this 
chapter.
    (c) Conditions of use. For implantation in heifers as follows:
    (1) Amount. (i) 20 milligrams (mg) estradiol benzoate and 200 mg 
testosterone propionate (one implant consisting of 8 pellets, each 
pellet containing 2.5 mg estradiol benzoate and 25 mg testosterone 
propionate) per implant dose.
    (ii) 20 mg estradiol benzoate and 200 mg testosterone propionate 
(one implant consisting of 9 pellets, each of 8 pellets containing 2.5 
mg estradiol benzoate and 25 mg testosterone propionate, and 1 pellet 
containing 29 mg tylosin tartrate) per implant dose.
    (2) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (3) Limitations. For heifers weighing 400 pounds or more; for 
subcutaneous ear implantation, one dose per animal; not for use in 
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 5, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-25977 Filed 11-23-04; 8:45 am]
BILLING CODE 4160-01-S