[Federal Register Volume 68, Number 61 (Monday, March 31, 2003)]
[Rules and Regulations]
[Page 15370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7534]


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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, Mometasone Furoate, Clotrimazole Otic Suspension

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 Schering-Plough Animal Health Corp. The 
supplemental NADA provides for the addition of once-daily 
administration to the dosage regimens for gentamicin/mometasone/
clotrimazole otic suspension used to treat otitis externa in dogs and 
for revision of the indications to reflect a current format.

DATES: This rule is effective March 31, 2003.

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: 
[email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., P.O. Box 3182, Union, NJ 07083, filed a supplement to NADA 
141-177 that provides for once-daily administration of MOMETAMAX 
(gentamicin sulfate/mometasone furoate monohydrate/clotrimazole) Otic 
Suspension for the treatment of otitis externa in dogs caused by 
susceptible strains of yeast (Malassezia pachydermatis) and bacteria 
(Pseudomonas spp. [including P. aeruginosa], coagulase-positive 
staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-
hemolytic streptococci). The indications for use are also being revised 
to reflect a current format. The supplemental NADA is approved as of 
January 9, 2003, and the regulations are amended in 21 CFR 524.1044h 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 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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this 
supplemental approval qualifies for 3 years of marketing exclusivity 
beginning January 9, 2003.
    The agency has determined under 21 CFR 25.33(d)(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 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 524.1044h is amended in paragraph (a) by removing ``3-'' and 
``1-'', and by adding in their respective places ``3'' and ``1''; in 
paragraph (c)(1) by adding ``once or'' before ``twice''; and by 
revising paragraph (c)(2) to read as follows:


Sec.  524.1044h  Gentamicin sulfate, mometasone furoate, clotrimazole 
otic suspension.

* * * * *
    (c) * * *
    (2) Indications for use. For the treatment of otitis externa caused 
by susceptible strains of yeast (Malassezia pachydermatis) and bacteria 
(Pseudomonas spp. [including P. aeruginosa], coagulase-positive 
staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-
hemolytic streptococci).
* * * * *

    Dated: March 21, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-7534 Filed 3-28-03; 8:45 am]
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