[Federal Register Volume 62, Number 83 (Wednesday, April 30, 1997)]
[Rules and Regulations]
[Pages 23357-23358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11080]



Food and Drug Administration

21 CFR Part 529

Certain Other Dosage Form New Animal Drugs; Amikacin Sulfate 

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.


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 Scientific, Inc. The ANADA 
provides for intrauterine use of amikacin sulfate solution in horses 
for the treatment of uterine infections.

EFFECTIVE DATE: April 30, 1997.

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

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, has filed 
ANADA 200-181, which provides for intrauterine use of amikacin sulfate 
solution for the treatment of uterine infections (endometritis, 
metritis, and pyometra) in mares, when caused by susceptible

[[Page 23358]]

organisms including Escherichia coli, Pseudomonas spp., and Klebsiella 
    The ANADA is approved as a generic copy of Fort Dodge Laboratories' 
NADA 127-892, Amiglyde-V (amikacin sulfate solution). ANADA 
200-181 is approved as of March 18, 1997, and the regulations are 
amended in 21 CFR 529.50 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 

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 as follows:


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

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

Sec. 529.50   [Amended]

    2. Section 529.50 Amikacin sulfate intrauterine solution is amended 
in paragraph (b) by adding the phrase ``and 059130'' after ``000856''.

    Dated: April 7, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-11080 Filed 4-29-97; 8:45 am]