[Federal Register: December 3, 2002 (Volume 67, Number 232)]
[Rules and Regulations]
[Page 71819-71820]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de02-11]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Ivermectin Paste
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 an abbreviated new animal drug
application (ANADA) filed by Virbac AH, Inc. The ANADA provides for
oral use of ivermectin paste in horses for treatment and control of
various internal parasites or parasitic conditions.
DATES: This rule is effective December 3, 2002.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail:
lluther@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft.
Worth, TX 76137, filed ANADA 200-320 for EQUELL (ivermectin) Paste. The
application provides for oral use of 1.87 percent ivermectin paste in
horses for the treatment and control of various species of internal
parasites or parasitic conditions. Virbac's EQUELL Paste is approved as
a generic copy of Merial Limited's EQUALEN Paste, approved under NADA
134-314. ANADA 200-320 is approved as of August 9, 2002, and 21 CFR
520.1192 is amended 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 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 Dockets Management Branch (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.
[[Page 71820]]
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 21 CFR Part 520
Animal drugs.
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1192 [Amended]
2. Section 520.1192 Ivermectin paste is amended in paragraph (b)(2)
by removing ``No.'' and by adding in its place ``Nos. 051311 and''.
Dated: November 18, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-30640 Filed 12-2-02; 8:45 am]
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