Document ID: FDA-2010-N-0002-0062
Agency: fda
Document Type: Rule
Title: Ophthalmic and Topical Dosage Form New Animal Drugs: Gentamicin and Betamethasone Ophthalmic Solution; Technical Amendment
Posted Date: 2010-09-08T04:00Z

[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Rules and Regulations]               
[Page 54492-54493]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se10-6]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

[Docket No. FDA-2010-N-0002]

 
Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin 
and Betamethasone Ophthalmic Solution

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 codify the conditions of use of an approved new 
animal drug application (NADA) for gentamicin sulfate and betamethasone 
acetate ophthalmic solution. This action is being taken to comply with 
the Federal Food, Drug, and Cosmetic Act and to improve the accuracy of 
the regulations.

DATES: This rule is effective September 8, 2010.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, email: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA has noticed that the approved conditions 
of use for GENTOCIN DURAFILM (gentamicin sulfate and betamethasone 
acetate) Ophthalmic Solution, sponsored by Intervet, Inc., 56 
Livingston Ave., Roseland, NJ 07068 under NADA 34-267 are not codified. 
When this NADA was approved in 1967, codification of approved 
conditions of use for NADAs was not required. Accordingly, the 
regulations are amended in 21 CFR part 524 by adding Sec.  524.1044i to 
reflect the approval. This action is being taken to comply with section 
512(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) 
and to improve the accuracy of the regulations.
    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

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

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

0
2. Add Sec.  524.1044i to read as follows:

Sec.  524.1044i  Gentamicin and betamethasone ophthalmic solution.

    (a) Specifications. Each milliliter (mL) of solution contains 
gentamicin sulfate equivalent to 3 milligrams (mg) of gentamicin base 
and 1 mg

[[Page 54493]]

betamethasone acetate equivalent to 0.89 mg betamethasone alcohol.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill one or two drops 
of solution in the conjunctival sac three or four times a day.
    (2) Indications for use. For treatment of external bacterial 
infections of the eye (conjunctiva and cornea).
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: September 1, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-22276 Filed 9-7-10; 8:45 am]
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