[Federal Register Volume 60, Number 9 (Friday, January 13, 1995)]
[Rules and Regulations]
[Page 3079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-899]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Neomycin Sulfate Oral 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 Phoenix Scientific, Inc. The ANADA 
provides for use of a generic neomycin sulfate oral solution in the 
drinking water and milk for cattle (excluding veal calves), swine, 
sheep, and goats for the treatment and control of colibacillosis.

EFFECTIVE DATE: January 13, 1995.

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: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
118, which provides for the use of neomycin oral solution (neomycin 
sulfate) in the drinking water and milk for cattle (excluding veal 
calves), swine, sheep, and goats for the treatment and control of 
colibacillosis (bacterial enteritis) caused by Escherichia coli 
susceptible to neomycin sulfate. Approval of ANADA 200-118 is as a 
generic copy of the Upjohn Co.'s approved NADA 11-315. The ANADA is 
approved as of November 29, 1994, and 21 CFR 520.1485(b) is amended to 
reflect the approval. The basis for approval is discussed in the 
freedom of information summary.
    In addition, the heading of the section is editorially revised to 
reflect the name of the product.
    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 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).
    2. Section 520.1485 is amended by revising the section heading and 
paragraph (b) to read as follows:
Sec. 520.1485  Neomycin sulfate oral solution.

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    (b) Sponsors. See Nos. 000009 and 059130 in Sec. 510.600(c) of this 
chapter.
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    Dated: January 3, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-899 Filed 1-12-95; 8:45 am]
BILLING CODE 4160-01-F