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Ophthalmic and Topical Dosage Form New Animal Drugs; Copper Naphthenate Solution

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 [Federal Register: July 5, 2006 (Volume 71, Number 128)]
[Rules and Regulations]
[Page 38073-38074]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jy06-12]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524

Ophthalmic and Topical Dosage Form New Animal Drugs; Copper 
Naphthenate Solution

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 Farnam Companies, Inc. The supplemental 
NADA provides for a revised food safety warning on labeling for copper 
naphthenate topical solution for horse and pony hooves.

DATES: This rule is effective July 5, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Farnam Companies, Inc., 301 West Osborn, 
Phoenix, AZ 85013-3928, filed a supplement to NADA 100-616 for THRUSH-
XX (copper naphthenate), a solution approved for topical use on horse 
and pony hooves as an aid in treating thrush. The supplemental NADA 
provides for a revised food safety warning on the labeling. The 
supplemental NADA is approved as of May 30, 2006, and the regulations 
are amended in 21 CFR 524.463 to reflect the approval and a current format.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(d)(3) 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 524

    Animal drugs.

[[Page 38074]]

? 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 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

? 1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

? 2. In Sec.  524.463, revise the section and paragraph (c) headings, and 
paragraphs (a) and (c)(3) to read as follows:

Sec.  524.463  Copper naphthenate.

    (a) Amount. The drug is a 37.5 percent solution of copper 
naphthenate.
* * * * *
    (c) Conditions of use in horses--* * *
* * * * *
    (3) Limitations. Use on horses and ponies only. Avoid contact 
around eyes. Do not contaminate feed. Do not use in horses intended for 
human consumption.

    Dated: June 22, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-10407 Filed 7-3-06; 8:45 am]
BILLING CODE 4160-01-S

 
 

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