[Federal Register Volume 63, Number 167 (Friday, August 28, 1998)]
[Rules and Regulations]
[Page 45944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23108]
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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 Soluble
Powder and 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 a supplemental abbreviated new
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The
supplemental ANADA provides for revised withdrawal times for oral
solution as a drench and in drinking water for the treatment and
control of colibacillosis in cattle (excluding veal calves), swine,
sheep, and goats.
EFFECTIVE DATE: August 28, 1998.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, is the sponsor
of ANADA 200-118 that provides for the use of neomycin sulfate soluble
powder and oral solution as a drench in milk, or in drinking water for
the treatment and control of colibacillosis in cattle (excluding veal
calves), swine, sheep, and goats. The sponsor filed a supplement that
provides for the revised withdrawal periods for the use of the generic
product to be identical to that of the pioneer product.
The supplemental ANADA is approved as a generic copy of Pharmacia &
Upjohn's NADA 011-315 Neomix. Supplemental ANADA 200-118 is
approved as of July 14, 1998, and the regulations are amended in 21 CFR
520.1485 to reflect the approval for the neomycin sulfate solution. The
basis for approval is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
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: 21 U.S.C. 360b.
Sec. 520.1485 [Amended]
3. Section 520.1485 Neomycin sulfate oral solution is amended in
paragraph (d)(3) by removing ``For sponsor 059130: 30 days for cattle
and goats, and 20 days for swine and sheep; for sponsors 000009 and
050604:''.
Dated: August 17, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-23108 Filed 8-27-98; 8:45 am]
BILLING CODE 4160-01-F
