[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]
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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; Amikacin Sulfate
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 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
spp.
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
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 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. 529.50 [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]
BILLING CODE 4160-01-F
