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

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 [Federal Register: September 29, 2003 (Volume 68, Number 188)]
[Rules and Regulations]
[Page 55825]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se03-16]

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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 an abbreviated new animal drug 
application (ANADA) filed by First Priority, Inc. The ANADA provides 
for topical use of copper naphthenate solution on horses and ponies as 
an aid in treating thrush caused by organisms susceptible to copper 
naphthenate.

DATES: This rule is effective September 29, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
lluther@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr., 
Elgin, IL 60123, filed ANADA 200-304 for PRITOX, a solution of copper 
naphthenate for topical application on horses and ponies as an aid in 
treating thrush caused by organisms susceptible to copper naphthenate. 
First Priority's PRITOX is approved as a generic copy of Ft. Dodge 
Animal Health's KOPERTOX, approved under NADA 12-991. The ANADA is 
approved as of July 25, 2003, and 21 CFR 524.463 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 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 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 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.

Sec.  524.463  [Amended]

? 2. Section 524.463 Copper naphthenate solution is amended in paragraph 
(b) by removing ``Sponsor'' and by adding in its place ``Sponsors''; 
and by removing ``000856 and 017135'' and by adding in its place 
``000856, 017135, and 058829''.

    Dated: September 15, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-24495 Filed 9-26-03; 8:45 am]
BILLING CODE 4160-01-S

 
 

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