[Federal Register: November 22, 2004 (Volume 69, Number 224)]
[Rules and Regulations]
[Page 67818-67819]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no04-7]
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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
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 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.
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: edubbin@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: 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.
List of Subjects in 21 CFR Part 522
Animal drugs.
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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, 21 CFR part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
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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 522.840 is revised to read as follows:
Sec. 522.840 Estradiol.
(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 Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 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.
[[Page 67819]]
(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.
Dated: November 10, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 04-25877 Filed 11-19-04; 8:45 am]
BILLING CODE 4160-01-S