[Federal Register Volume 62, Number 218 (Wednesday, November 12, 1997)]
[Rules and Regulations]
[Pages 60656-60657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29654]
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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 a supplemental abbreviated new
animal drug application (ANADA) filed by Pharmacia & Upjohn Co. The
supplemental ANADA provides for a shorter withdrawal period following
use of neomycin sulfate oral solution in the drinking water or in milk
for cattle (excluding veal calves), swine, sheep, and goats for the
treatment and control of colibacillosis.
EFFECTIVE DATE: November 12, 1997.
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: Pharmacia & Upjohn Co., 7000 Portage Rd.,
Kalamazoo, MI 49001-0199, filed supplemental ANADA 200-113 that
provides for a shorter withdrawal period following use of neomycin
sulfate oral solution in the drinking water or in 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 supplemental ANADA 200-113 is as a generic copy of the
sponsor's approved supplemental NADA 11-315. The supplemental ANADA is
approved as of February 7, 1997, and the regulations are amended in
Sec. 520.1485(d)(3) (21 CFR 520.1485(d)(3)) to reflect the approval.
The previously approved supplement to NADA 11-315 included data to
support revised tolerances for residues of neomycin in the edible
tissues of cattle, swine, sheep, and goats. Based on evaluation of the
data as provided in the ``General Principles for Evaluating the Safety
of Compounds Used in Food-Producing Animals Guidelines,'' tolerances of
1.2 parts per million (ppm) in muscle, 3.6 ppm in liver, and 7.2 ppm in
kidney and fat, and withdrawal times of 1 day for cattle, 2 days for
sheep, and 3 days for swine and goats were established. The revised
withdrawal times were established in 21
[[Page 60657]]
CFR 520.1484(c)(3) and now for ANADA 200-113 in Sec. 520.1485(d)(3).
No additional effectiveness or safety studies were required for
this approval. Therefore, a freedom of information summary is not
required. A summary of data and information submitted to support the
original ANADA approval 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 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.
2. Section 520.1485 is amended by revising the last sentence of
paragraph (d)(3) to read as follows:
Sec. 520.1485 Neomycin sulfate oral solution.
* * * * *
(d) * * *
(3) * * * Discontinue treatment prior to slaughter as follows: For
sponsor 059130: 30 days for cattle and goats, and 20 days for swine and
sheep; for sponsors 000009 and 050604: 1 day for cattle, 2 days for
sheep, and 3 days for swine and goats.
Dated: October 10, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-29654 Filed 11-10-97; 8:45 am]
BILLING CODE 4160-01-F
