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Implantation or Injectable Dosage Form New Animal Drugs; Estradiol

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.


Final rule.


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 Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental NADA provides for the addition of statements to labeling of subcutaneous implants containing estradiol warning against the use of these products in calves to be processed for veal.


This rule is effective November 22, 2004.

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Eric S. Dubbin, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0232, e-mail:

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Ivy Laboratories, Division of Ivy Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a supplement to NADA 118-123 for ENCORE (estradiol) and COMPUDOSE (estradiol). 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 522.840 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), 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.

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List of Subjects in 21 CFR Part 522

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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,

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1. The authority citation for

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

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2. Section 522.840 is revised to read as follows:

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(a) Specifications. Each silicone rubber implant contains 25.7 or 43.9 milligrams (mg) estradiol and is coated with not less than 0.5 mg oxytetracycline powder.

(b) Sponsor. See No. 021641 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.240 of this chapter.

(d) Conditions of use. For implantation in steers and heifers as follows:

(1) Amount. Insert one 25.7-mg implant every 200 days; insert one 43.9-mg implant every 400 days.

(2) Indications for use. For increased rate of weight gain in suckling and pastured growing steers; for improved feed efficiency and increased rate of weight gain in confined steers and heifers. No additional effectiveness may be expected from reimplanting in less than 200 days for the 25.7-mg implant or 400 days for the 43.9-mg implant.

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(3) Limitations. For subcutaneous ear implantation in steers and heifers 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.

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Dated: November 10, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

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[FR Doc. 04-25877 Filed 11-19-04; 8:45 am]