[Federal Register Volume 68, Number 139 (Monday, July 21, 2003)]
[Rules and Regulations]
[Pages 42969-42970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18353]


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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, Betamethasone Valerate, Clotrimazole Ointment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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 Phoenix Scientific, Inc. The ANADA 
provides for the use of gentamicin sulfate, betamethasone valerate, and 
clotrimazole ointment for the treatment of canine otitis externa.

DATES: This rule is effective July 21, 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: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, St. Joseph, MO 64503, filed ANADA 200-287 that provides 
for use of gentamicin sulfate, United States Pharmacopeia (USP); 
betamethasone valerate, USP; and clotrimazole, USP; (GBC) Ointment for 
the treatment of canine otitis externa associated with yeast 
(Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria 
susceptible to gentamicin. Phoenix Scientific's GBC Ointment is 
approved as a generic copy of Schering-Plough Animal Health's OTOMAX 
Ointment approved under NADA 140-896. The ANADA is approved as of March 
28, 2003, and the regulations are amended in Sec.  524.1044g (21 CFR 
524.1044g) to reflect the approval. The basis of approval is discussed 
in the freedom of information summary.
    In addition, Sec.  524.1044g is being amended to reflect the 
supplemental approval of several additional container sizes under NADA 
140-896 and ANADA 200-229, which were not codified, and to reflect a 
current format.
    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.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner

[[Page 42970]]

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

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
0
2. Section 524.1044g is amended by revising paragraphs (b) and (c) to 
read as follows:


Sec.  524.1044g  Gentamicin sulfate, betamethasone valerate, 
clotrimazole ointment.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
uses as in paragraph (c) of this section.
    (1) No. 000061 for use of 7.5- or 15-gram (g) tubes, 12.5-, 30-, or 
215-g bottles.
    (2) No. 051259 for use of 7.5- or 15-g tubes, 10-, or 25-g bottles.
    (3) No. 059130 for use of 10- or 215-g bottles.
    (c) Conditions of use in dogs--(1) Amount. Instill ointment twice 
daily into the ear canal. Therapy should continue for 7 consecutive 
days.
    (i) From 7.5- or 15-g tubes, 10-, 12.5-, 25-, or 30-g bottles: 4 
drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs 
weighing 30 lb or more.
    (ii) From 215-g bottles: 2 drops for dogs weighing less than 30 lb 
or 4 drops for dogs weighing 30 lb or more.
    (2) Indications for use. For the treatment of canine otitis externa 
associated with yeast (Malassezia pachydermatis, formerly Pityrosporum 
canis) and/or bacteria susceptible to gentamicin.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: July 3, 2003.
Andrew J. Beaulieu,
Associate Director, Center for Veterinary Medicine.
[FR Doc. 03-18353 Filed 7-18-03; 8:45 am]
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