[Federal Register Volume 72, Number 26 (Thursday, February 8, 2007)]
[Rules and Regulations]
[Pages 5929-5930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2121]


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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 
and Betamethasone Spray

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 a gentamicin sulfate and betamethasone valerate 
topical spray on dogs for the treatment of infected superficial 
lesions.

DATES:  This rule is effective February 8, 2007.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr., 
Elgin, IL 60123, filed ANADA 200-415 for Gentamicin Sulfate Topical 
Spray (gentamicin sulfate, USP with betamethasone valerate, USP) for 
use on dogs for the treatment of infected superficial lesions caused by 
bacteria sensitive to gentamicin. First Priority's Gentamicin Sulfate 
Topical Spray is approved as a generic copy of Schering-Plough Animal 
Health Corp.'s GENTOCIN Topical Spray, approved under NADA 132-338. The 
ANADA is approved as of January 12, 2006, and 21 CFR 524.1044f 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. In Sec.  524.1044f, revise the section heading and paragraph (b) to 
read as follows:


Sec.  524.1044f  Gentamicin and betamethasone spray.

* * * * *
    (b) See Nos. 000061, 054925, and 058829 in Sec.  510.600(c) of this 
chapter.
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[[Page 5930]]


    Dated: January 29, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-2121 Filed 2-7-07; 8:45 am]
BILLING CODE 4160-01-S