[Federal Register Volume 71, Number 169 (Thursday, August 31, 2006)]
[Rules and Regulations]
[Page 51727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7307]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529


Certain Other Dosage Form New Animal Drugs; Gentamicin Sulfate 
Intrauterine Solution

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 Sparhawk Laboratories, Inc. The ANADA 
provides for use of a generic gentamicin sulfate solution as an 
intrauterine infusion for the control of bacterial metritis and as an 
aid in improving conception in mares.

DATES: This rule is effective August 31, 2006.

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: Sparhawk Laboratories, Inc., 12340 Santa Fe 
Trail Dr., Lenexa, KS 66215, filed ANADA 200-395 for the use of 
Gentamicin Sulfate Solution for the control of bacterial infections of 
the uterus (metritis) and as an aid in improving conception in mares 
with uterine infections caused by bacteria sensitive to gentamicin. 
Sparhawk Laboratories, Inc.'s gentamicin sulfate solution is approved 
as a generic copy of Schering-Plough Animal Health Corp.'s GENTOCIN 
(gentamicin sulfate) solution veterinary, approved under NADA 46-724. 
The ANADA is approved as of July 31, 2006, and the regulations in 21 
CFR 529.1044a are 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.
    FDA 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 529

    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 529 is 
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 529 continues to read as 
follows:

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


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2. Revise Sec.  529.1044a to read as follows:


Sec.  529.1044a  Gentamicin sulfate intrauterine solution.

    (a) Specifications. Each milliliter of solution contains 50 or 100 
milligrams gentamicin sulfate.
    (b) Sponsors. See Nos. 000010, 000061, 000856, 057561, 058005, 
059130, and 061623 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Infuse 2 to 2.5 grams 
per day for 3 to 5 days during estrus.
    (2) Indications for use. For control of bacterial infections of the 
uterus (metritis) and as an aid in improving conception in mares with 
uterine infections caused by bacteria sensitive to gentamicin.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: August 11, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-7307 Filed 8-30-06; 8:45 am]
BILLING CODE 4160-01-S