[Federal Register: December 5, 2001 (Volume 66, Number 234)]
[Rules and Regulations]
[Page 63164-63165]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de01-7]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 524
Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin
Pour-On
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
topical use of ivermectin on cattle for treatment and control of
various species of external and internal parasites.
DATES: This rule is effective December 5, 2001.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail:
lluther@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft.
Worth, TX 76137, filed ANADA 200-318 for VIRBAMEC (ivermectin) Pour-On.
The ANADA provides for topical use of 0.5 percent ivermectin solution
on cattle for the treatment and control of various species of
gastrointestinal nematodes, lungworms, grubs, horn flies, lice, and
mites. Virbac's VIRBAMEC Pour-On is approved as a generic copy of
Merial Ltd.'s IVOMEC Pour-On for Cattle, approved under NADA 140-841.
The ANADA 200-318 is approved as of September 21, 2001, and the
regulations in 21 CFR 524.1193 are amended to reflect the approval. The
basis of approval is discussed in the freedom of information summary.
In addition, Virbac AH, Inc., has not been previously listed in the
animal drug regulations as a sponsor of an approved application. At
this time, 21 CFR 510.600(c) is being amended to add entries for the
firm.
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.
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 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 524
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 parts 510 and
524 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
2. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding an entry for ``Virbac AH, Inc.'' and in the table
in paragraph (c)(2) by numerically adding an entry for ``051311'' to
read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 63165]]
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Firm name and address Drug labeler code
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* * * *
* * *
Virbac AH, Inc., 3200 051311
Meacham Blvd., Ft. Worth,
TX 76137
* * * *
* * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * *
* * *
051311 Virbac AH, Inc., 3200
Meacham Blvd., Ft. Worth,
TX 76137
* * * *
* * *
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PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1193 [Amended]
4. Section 524.1193 Ivermectin pour-on is amended in paragraph (b)
by adding ``051311,'' after ``051259,'' and in paragraph (e)(2) by
removing ``Damalina'' and by adding in its place ``Damalinia''.
Dated: November 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-30037 Filed 12-4-01; 8:45 am]
BILLING CODE 4160-01-S