[Federal Register Volume 62, Number 103 (Thursday, May 29, 1997)]
[Rules and Regulations]
[Pages 29012-29013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14109]
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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 Soluble
Powder
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 Agri-Laboratories, Ltd. The ANADA provides
for the use of gentamicin sulfate soluble powder for use in swine
drinking water for the control and treatment of colibacillosis in
weanling swine and for swine dysentery.
EFFECTIVE DATE: May 29, 1997.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Agri Laboratories, Ltd., P.O. Box 3103, St.
Joseph, MO 64503, filed ANADA 200-185, which provides for the use of
Gen-GardTM (gentamicin sulfate) soluble powder in swine
drinking water for the control and treatment of colibacillosis in
weanling swine caused by strains of Escherichia coli sensitive to
gentamicin, and the control and treatment of swine dysentery associated
with Treponema hyodysenteriae.
ANADA 200-185 is approved as a generic copy of the Schering-Plough
Corp.'s Garacin (gentamicin) soluble powder in NADA 133-836.
The ANADA is approved as of April 30, 1997, and the regulations are
amended in 21 CFR 520.1044c(b) to reflect the approval. The basis of
approval is discussed in the freedom of information summary.
[[Page 29013]]
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. 520.1044c [Amended]
2. Section 520.1044c Gentamicin sulfate soluble powder is amended
in paragraph (b) by removing ``No. 000061'' and adding in its place
``Nos. 000061 and 057561''.
Dated: May 19, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-14109 Filed 5-28-97; 8:45 am]
BILLING CODE 4160-01-F
