[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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