[Federal Register Volume 62, Number 103 (Thursday, May 29, 1997)]
[Rules and Regulations]
[Pages 29011-29012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14103]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Gentamicin Sulfate
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 use of gentamicin sulfate pig pump oral solution for the
control and treatment of colibacillosis in neonatal pigs 1 to 3 days of
age.
EFFECTIVE DATE: May 29, 1997.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
Street Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, has filed
ANADA 200-174, which provides for the control and treatment of
colibacillosis in neonatal pigs 1 to 3 days of age caused by strains of
Escherichia coli sensitive to gentamicin.
The ANADA is approved as a generic copy of Schering-Plough Animal
Health's, Garason Pig Pump (gentamicin sulfate oral solution)
NADA 130-464. ANADA 200-174 is approved as of April 10, 1997, and the
regulations are amended in 21 CFR 520.1044b 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 520
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 520.1044b [Amended]
2. Section 520.1044b Gentamicin sulfate pig pump oral solution is
amended in paragraph (b) by adding
[[Page 29012]]
after ``000061'' the phrase ``and 059130''.
Dated: May 19, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-14103 Filed 5-28-97; 8:45 am]
BILLING CODE 4160-01-F
