[Federal Register Volume 69, Number 150 (Thursday, August 5, 2004)]
[Rules and Regulations]
[Page 47363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17891]


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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; Gentamicin 
Sulfate Ophthalmic Ointment

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 Altana Inc. The ANADA provides for 
veterinary prescription use of gentamicin sulfate ophthalmic ointment 
on dogs and cats for topical treatment of conjunctivitis caused by 
susceptible bacteria.

DATES: This rule is effective August 5, 2004.

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: 
[email protected].

SUPPLEMENTARY INFORMATION: Altana Inc., 60 Baylis Rd., Melville, NY 
11747, filed ANADA 200-273 for veterinary prescription use of VETRO-GEN 
(gentamicin sulfate) Veterinary Ophthalmic Ointment on dogs and cats 
for topical treatment of conjunctivitis caused by susceptible bacteria. 
Altana Inc.'s VETRO-GEN Veterinary Ophthalmic Ointment is approved as a 
generic copy of Schering-Plough Animal Health's GENTOCIN Ophthalmic 
Ointment, approved under NADA 98-989. The ANADA is approved as of June 
8, 2004, and 21 CFR 524.1044c is amended to reflect the approval and a 
current format. 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.

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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

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

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

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2. Section 524.1044c is revised to read as follows:


Sec.  524.1044c  Gentamicin sulfate ophthalmic ointment.

    (a) Specifications. Each gram of ointment contains gentamicin 
sulfate equivalent to 3 milligrams of gentamicin.
    (b) Sponsors. See Nos. 000061 and 025463 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Apply 
approximately a 1/2-inch strip to the affected eye 2 to 4 times a day.
    (2) Indications for use. For treatment of conjunctivitis caused by 
susceptible bacteria.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: June 23, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-17891 Filed 8-4-04; 8:45 am]
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