[Federal Register Volume 66, Number 234 (Wednesday, December 5, 2001)]
[Rules and Regulations]
[Pages 63164-63165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30037]


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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: 
[email protected].

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