[Federal Register Volume 60, Number 183 (Thursday, September 21, 1995)]
[Rules and Regulations]
[Pages 48893-48894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23353]
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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.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
[[Page 48894]]
animal drug regulations to reflect approval of an abbreviated new
animal drug application (ANADA) filed by Fermenta Animal Health Co. 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: (September 21,1995.)
FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary
Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1612.
SUPPLEMENTARY INFORMATION: Fermenta Animal Health Co., 10150 North
Executive Hills Blvd., Kansas City, MO 64153, is the sponsor of ANADA
200-023, which provides for the use of a generic gentamicin solution
(100 milligrams/milliter (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 200-023 for Fermenta Animal Health Co.'s gentamicin sulfate
solution (100 mg/mL gentamicin) is approved as a generic copy of
Schering's Gentocin Solution (100mg/mL gentamicin) in NADA
046-724. The ANADA is approved as of August 4, 1995, 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 to read 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, 000856, 057561, and
058711'' and adding in its place ``000061, 000856, 054273, 057561, and
058711''.
Dated: September 5, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-23353 Filed 9-20-95; 8:45 am]
BILLING CODE 4160-01-F
