[Federal Register Volume 61, Number 120 (Thursday, June 20, 1996)]
[Rules and Regulations]
[Pages 31397-31398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15566]



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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 Rhone Merieux, Inc. The ANADA provides for 
the use of a generic neomycin sulfate oral solution in drinking water 
or in milk for cattle (excluding veal calves), swine, sheep, and goats 
for the treatment and control of colibacillosis.

EFFECTIVE DATE: June 20, 1996.

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: Rhone Merieux, Inc., 7101 College Blvd., 
Overland Park, KS 66210, filed ANADA 200-153, which provides for the 
use of neomycin sulfate oral solution in drinking water or in milk of 
cattle (excluding veal calves), swine, sheep, and goats for the 
treatment and control of colibacillosis (bacterial scours) caused by 
Escherichia coli susceptible to neomycin. ANADA 200-153 is approved as 
a generic copy of The Upjohn Co.'s NADA 11-035. The ANADA is approved 
as of May 8, 1996, and the regulations are amended in 21 CFR 
520.1485(b) and (d)(3) 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

[[Page 31398]]

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, 12420 
Parklawn Dr., rm. 1-23, 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 paragraph (b) and the 
last sentence of paragraph (d)(3) to read as follows:


Sec. 520.1485  Neomycin sulfate oral solution.

*- * * * *
    (b) Sponsors. See Nos. 000009, 050604, and 059130 in 
Sec. 510.600(c) of this chapter.
* * * * * -
    (d) * * *
    (3) * * * Discontinue treatment prior to slaughter as follows: For 
sponsors 000009 and 059130: 30 days for cattle and goats, and 20 days 
for swine and sheep; for sponsor 050604: 1 day for cattle (not for use 
in veal calves), 2 days for sheep, and 3 days for swine and goats.

    Dated: June 10, 1996.
Shephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-15566 Filed 6-19-96; 8:45 am]
BILLING CODE 4160-01-F