[Federal Register Volume 62, Number 83 (Wednesday, April 30, 1997)]
[Rules and Regulations]
[Page 23357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11085]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; Amikacin 
Sulfate Injection

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 the use of amikacin sulfate injection for the treatment of 
the following conditions in dogs: genitourinary tract infections 
(cystitis) caused by susceptible strains of Escherichia coli and 
Proteus spp. and skin and soft tissue infections caused by susceptible 
strains of Pseudomonas spp. and E. coli.

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 200-178, which provides for the use of amikacin sulfate injection 
for the treatment of the following conditions in dogs: genitourinary 
tract infections (cystitis) caused by susceptible strains of E. coli 
and Proteus spp. and skin and soft tissue infections caused by 
susceptible strains of Pseudomonas spp. and E. coli.
    The ANADA is approved as a generic copy of Fort Dodge Laboratories, 
Inc., NADA 127-892, Amiglyde-V Injection (amikacin sulfate 50 
milligrams per milliliter). ANADA 200-178 is approved as of March 14, 
1997, and the regulations are amended in 21 CFR 522.56 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 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

Sec. 522.56  [Amended]

    2. Section 522.56 Amikacin sulfate injection is amended in 
paragraph (b) by removing ``000856'' and adding in its place ``Nos. 
000856 and 059130''.

    Dated: April 7, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-11085 Filed 4-29-97; 8:45 am]
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