[Federal Register Volume 60, Number 168 (Wednesday, August 30, 1995)]
[Rules and Regulations]
[Pages 45041-45042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21455]



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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 animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by Macleod Pharmaceuticals, Inc. 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: August 30, 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.


[[Page 45042]]

SUPPLEMENTARY INFORMATION: Macleod Pharmaceuticals, Inc., 2600 Canton 
Ct., Fort Collins, CO 80525, is the sponsor of ANADA 200-115, 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.
    Approval of ANADA 200-115 for Macleod Pharmaceuticals' gentamicin 
sulfate solution (100 mg/mL gentamicin) is as a generic copy of 
Schering's Gentocin Solution (100mg/mL gentamicin) in NADA 
046724. The ANADA is approved as of July 21, 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 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, 057561, and 000856'' and 
adding in its place ``000061, 000856, 057561, and 058711''.

    Dated: August 14, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-21455 Filed 8-29-95; 8:45 am]
BILLING CODE 4160-01-F