[Federal Register Volume 62, Number 3 (Monday, January 6, 1997)]
[Rules and Regulations]
[Page 611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-185]


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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 Phoenix Pharmaceutical, Inc. The ANADA 
provides for the use of a generic gentamicin sulfate intrauterine 
solution for control of bacterial infections of the uterus in horses 
(metritis) and as an aid in improving conception in mares with uterine 
infections caused by bacteria sensitive to gentamicin.

EFFECTIVE DATE: January 6, 1997.

FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1617.

SUPPLEMENTARY INFORMATION: Phoenix Pharmaceutical, Inc., 4621 Easton 
Rd., P.O. Box 6457, Fairleigh Station, St. Joseph, MO 64506-0457, is 
the sponsor of ANADA 200-137, which provides for the use of a generic 
gentamicin sulfate intrauterine solution (100 milligrams/milliliter 
(mg/mL)) for control of bacterial infections of the uterus in horses 
(metritis) and as an aid in improving conception in mares with uterine 
infections caused by bacteria sensitive to gentamicin.
    Approval of ANADA 200-137 for Phoenix Pharmaceutical's gentamicin 
sulfate intrauterine solution (100 mg/mL gentamicin) is as a generic 
copy of Schering's Gentocin Solution (100 mg/mL gentamicin) 
in NADA 046-724. The ANADA is approved as of November 13, 1996, and the 
regulations are amended in 21 CFR 529.1044a to reflect the approval. 
The basis for approval is discussed in the freedom of information 
summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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.

List of Subjects in 21 CFR Part 529

    Animal drugs.
    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 to read as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

Sec. 529.1044a  [Amended]

    2. Section 529.1044a Gentamicin sulfate intrauterine solution is 
amended in paragraph (b) by removing ``000061, 000856, 000864, 054273, 
and 057561'' and adding in its place ``000061, 000856, 000864, 054273, 
057319, and 057561''.


    Dated: December 23, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-185 Filed 1-3-97; 8:45 am]
BILLING CODE 4160-01-F