[Federal Register Volume 59, Number 116 (Friday, June 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14854]
[[Page Unknown]]
[Federal Register: June 17, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 529
Certain Other Dosage Form New Animal Drugs; Gentamicin Sulfate
Intrauterine Solution
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
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 Fort Dodge Laboratories. The ANADA
provides for the use of a generic gentamicin solution for control of
bacterial infections of the uterus (metritis) of horses and as an aid
in improving conception in mares with uterine infections caused by
bacteria sensitive to gentamicin.
EFFECTIVE DATE: June 17, 1994.
FOR FURTHER INFORMATION CONTACT: Larry D. Rollins, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1612.
SUPPLEMENTARY INFORMATION: Fort Dodge Laboratories, Fort Dodge, IA
50501, is the sponsor of ANADA 200-102, which provides for the use of a
generic gentamicin solution (100 milligrams/milliliter (mg/mL)) for
control of bacterial infections of the uterus (metritis) in horses and
as an aid in improving conception in mares with uterine infections
caused by bacteria sensitive to gentamicin.
ANADA 200-102 for Fort Dodge Laboratories' gentamicin sulfate
solution (100 mg/mL gentamicin) is as a generic copy of Schering's
Gentocin Solution (100 mg/mL gentamicin) in NADA 046-724. The ANADA is
approved as of May 19, 1994, and the regulations are amended in 21 CFR
529.1044a 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 part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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. 529.1044a [Amended]
2. Section 529.1044a Gentamicin sulfate intrauterine solution is
amended in paragraph (b) by removing ``000061 and 057561'' and adding
in its place ``000061, 057561, and 000856''.
Dated: June 9, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-14854 Filed 6-16-94; 8:45 am]
BILLING CODE 4160-01-F
